Regulatory

Daiichi Sankyo

Associate Director, Regulatory Writing

Job Description

Job Title: Associate Director, Regulatory Writing

Job Requisition ID: 2340

Posting Start Date: 10/14/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The Associate Director, Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections of INDs, NDAs, BLAs, MAAs.. This role will also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director, Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).

**Job Description**

**Responsibilities**

- Write critical, complex clinical and clinical pharmacology documents (eg, pivotal Phase 3 CSRs, NDA/BLA/MAA submission documents, and briefing books) with minimal input from functional area experts;
- Ensure key messages are clear and consistent within and across documents
- Critically review documents produced by other writers for scientific content and alignment with company position, clarity, accuracy, and consistency
- Contribute strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data, and support the authoring of documents for filings or responding to health authority requests;
- Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents
- Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, potential collaborations and drive changes as needed.
- Assess resource requirements, proactively identify issues and solutions, and contribute to the development of timelines and processes

**Qualifications**

**Education Qualifications**

- Bachelor's Degree required
- Master's Degree or PhD in relevant science field preferred

**Experience Qualifications**

- 4+ years of experience as a medical writer with a graduate degree (Doctorate preferred) in a relevant science field or 7+ years of experience as a medical writer with a Bachelor's degree in a relevant science field required
- Submission document writing experience required

**Travel Requirements**

Ability to travel up to 5% of the time. In-house/remote office position that may require domestic/global travel.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$157,920.00 - USD$236,880.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

New Jersey

Senior Manager Global Regulatory Affairs CMC

The Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for:

Partnering closely with CSL’s R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio.

Defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products.

Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies.

This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.

Main Responsibilities and Accountabilities

Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio, collaborating closely with cross-functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.

Manage the development and submission of high-quality, compliant CMC regulatory submissions and submission components, including new marketing applications, clinical trial applications, variations/supplements, periodic compliance reports and renewals. Ensure timely execution aligned with regulatory expectations and business goals.

Ensure accurate and timely change control assessments of change control notifications in CSL’s quality management system for biological & non-biol. product-related change controls. This includes the country-specific reporting category and detailed submission documentation requirements.

Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSL’s competitive positioning for its biological & non-biol. product portfolio.

Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies. Maintain strong, positive relationships with regulators and ensure timely responses to inquiries and requests. Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management.

Develop strategic and tactical plans for Global Regulatory Affairs CMC, advising Global Regulatory Affairs CMC leadership and CSL stakeholders on regulatory requirements and their implications for project timelines, compliance, and business strategy. Contribute to the evaluation of new business opportunities in collaboration with development teams.

Provide regulatory consultation to internal CSL functions, including Global Operation functions, R&D, and IT, to support the design and implementation of business processes that ensure regulatory compliance and operational excellence.

Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations.

Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company’s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.

Ensure regulatory policies and procedures are developed and implemented in accordance with applicable international standards and requirements.

Support the creation and execution of regulatory policies, processes, and SOPs that meet global regulatory requirements while driving operational efficiency and effectiveness across Global Operations and its stakeholder network.

Support the outsourcing of regulatory activities, including submission quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements.

Position Qualifications and Experience Requirements

Education & Experience

A bachelor’s degree in biological or chemical sciences, or a related field is required; an advanced degree (e.g., MS, PhD) is strongly preferred.

Over 5 years of progressive experience in regulatory roles within the biologics or plasma industry, demonstrating increasing levels of responsibility.

Strong technical foundation with in-depth knowledge of global regulations and international standards governing drug product development, manufacture, registrations, and life-cycle management.

Proven expertise in authoring, reviewing, and managing regulatory submissions ensuring accuracy, compliance, and timely delivery.

Demonstrated ability to lead cross-functional teams and collaborate effectively with key stakeholders.

Skilled in motivating, mentoring, and guiding diverse teams within a matrixed organizational structure, fostering a culture of accountability and excellence.

Exceptional oral and written communication skills, with a strong ability to negotiate, influence, and represent regulatory positions effectively.

Committed to the highest standards of compliance, integrity, and adaptability, with a strong focus on aligning regulatory strategy with evolving business needs.

Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve goals.

Competencies

Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.

Drives Results: Has a strong bottom-line orientation; Persists in accomplishing objectives despite obstacles and setbacks; Has a track record of exceeding goals successfully; Pushes self and helps others achieve results.

Drives Vision & Purpose: Talks about future possibilities in a positive way; Creates milestones and symbols to rally support behind the vision; Articulates the vision in a way everyone can relate to; Creates organization-wide energy and optimism for the future; Shows personal commitment to the vision.

Instills Trust: Follows through on commitments; Is seen as direct and truthful; Keeps confidences; Practices what he/she preaches; Shows consistent between words and actions.

Communicates Effectively: Is effective in a variety of communication settings: one-on-one, small and large groups, among diverse styles and position levels, with internal and external stakeholders/audiences. Attentively listens to others; Adjusts to fit the audience and the message; Provides timely and helpful information to others across the organization; Encourages the open expression of diverse ideas and opinions.

Builds Effective Teams: Establishes common objectives and a shared mindset; Creates a feelings of belonging and strong team morale; Shares wins and rewards team efforts; Fosters open dialogue and collaboration among the team.

Drives Engagement: Structures the work so it aligns with people's goals and motivators; Empowers others; Makes each person feel his/her contributions are important; Invites input and shares ownership and visibility; Shows a clear connection between people's motivators and the organizational goals.

Manages Ambiguity: Deals comfortably with the uncertainty of change; Effectively handles risk; Can decide and act without the total picture; Is calm and productive, even when things are up in the air; Deals constructively with problems that do not have clear solutions or outcomes.

Collaborates: Works cooperatively with others across the site, matrix, network and enterprise to achieve shared objectives; Represents own interests while being fair to others and their areas; Partners with others to get work done; Credits others for their contributions and accomplishments; Gains trust and support of others.

Decision Quality: Makes sound decisions, even in the absence of complete information; Relies on a mixture of analysis, wisdom, experience, and judgment when making decisions; Considers all relevant factors and uses appropriate decision-making criteria and principles; Recognizes when a quick 80% solution will suffice.

Global Perspective: Looks toward the broadest possible view of an issue or challenge; Thinks and talks in global and network terms; Understands the position of the organization within a global, network and enterprise context; Knows the impact of global trends on the organization.

Being Resilient: Is confident under pressure; Handles and manages crises effectively; Maintains a positive attitude despite adversity; Bounces back from setbacks; Grows from hardships and negative experiences.

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.cslbenefits.com/csl/candidates>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Pennsylvania

AbbVie

Research Associate Scientist II

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

At DJS-AbbVie, we are committed to advancing new therapeutics and translating novel immunological science into innovative R&D programs. As a UK-based R&D hub within AbbVie Immunology, we combine the agility, scientific focus and entrepreneurial spirit of a specialist discovery team with the scale, resources and ambition of a global pharmaceutical company.

A critical part of achieving our vision is working with fantastic people, and as such we are looking for an enthusiastic and talented Associate Scientist II to join our Immunobiology team, whose goal is to deliver new insights into the biology and mechanisms of immunological disease, and valid targets for therapeutic intervention. For this role, candidates should be excited about working in a small, dynamic team; always keen to get involved with all aspects of immunobiology and drug discovery research; be a team player. This position represents an excellent opportunity for someone looking to solidify their career within an industry laboratory research environment working on innovative projects whilst developing a variety of new skills.

The initial focus of a successful candidate will be to develop and use assays, including complex *in vitro* models, to answer focussed biological questions. You will need to work independently on primary cell culture, flow cytometry, ELISA, imaging, and various assay techniques, with appropriate guidance from senior team members.

The successful applicant will be a practical person who is organised, detail-oriented and efficient, and who enjoys working on experimental design and interpretation, and is excited about understanding novel biology. Some previous experience in basic immunological techniques is required.

At DJS we want to foster innovative scientists performing cutting edge science and as such a successful applicant will have numerous opportunities to grow. You will have the space to develop as an increasingly independent experimentalist, and get exposure to scientists from a range of background including bioinformaticians, clinical scientists, pathologists and drug discovery experts including with colleagues in our on-site Novel Therapeutics group in Oxford. You will be expected to work closely with Abbvie R&D colleagues, gaining experience in cross-border collaboration, and will have the opportunity to travel to AbbVie’s US research sites and network with scientists across different disease areas and disciplines.

**Successful applicant's key responsibilities**

- Bringing energy, enthusiasm and positivity to the company
- Maintenance of cell cultures including advanced primary cells.
- Techniques such as flow cytometry, fluorescence microscopy and ELISA
- Troubleshooting and execution of co-cultures and complex *in vitro* model systems
- Work as a key member of the Oxford immunobiology team but collaborating and working on whatever project is necessary to advance our therapeutic programs.
- Autonomously performing critical laboratory experiments and interpreting the data to drive the next series of experiments you will run and strategic decisions within you team.
- Keeping up to date with developments in the literature in relation to technical aspects of drug discovery technologies
- Day-to-day laboratory management as part of the team e.g. maintaining a safe and clean working laboratory environment, re-ordering laboratory consumables
- Establishing and maintaining quality sample archives
- Gathering, analysing and presenting data from a variety of sources to the Oxford team as well as to US-based colleagues.
- Critical and impartial review of self and peer generated laboratory data
- Maintenance of laboratory experimental records

Qualifications

- Bsc in a relevant discipline plus 2 years of industry experience, which may include placement years or internships, or an Msc degree.
- Enthusiasm for and commitment to drug discovery and drug development research
- Proven recent experience in
  - Mammalian cell culture
  - Cell biology techniques (such as flow cytometry; ELISA; fluorescence microscopy)
- Evidence of excellent organizational and interpersonal skis including
  - Ability to work both independently and as part of a team
  - Ability to work efficiently with strong attention to detail
  - Ability to build effective working relationships
  - Laboratory method development
  - Ability to work flexible hours when required
  - Proven written and oral communicative ability
  - Problem-solving skills
  - Strong IT skills
- Desirable skills
  - Experience in running functional *in vitro* or *ex vivo* biological assays on primary cells.
  - Good knowledge of statistics

Additional Information

**About DJS Antibodies**

At DJS Antibodies as part of AbbVie our ambition is to contribute world class novel antibody therapeutics for the treatment of severe diseases into AbbVie’s clinical pipeline. Our proprietary antibody discovery technology enables us to discover first in class antibodies to the key drivers of disease that have, until now, been intractable to drug discovery such as GPCR’s and other complex membrane and soluble targets.

Working at DJS will involve coming into a stimulating and entrepreneurial work environment with excellent exposure to industry-leading experts. Being part of a small team means that you will be exposed to all aspects of R&D and the broader business. You will benefit from working with a great team, a competitive remuneration package and significant opportunities for career development.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Other Non-US

China PV Lead

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

**Oversight of the Pharmacovigilance System**

- Ensures that PV processes, procedures and systems are in place to comply with AbbVie Global PV procedures and with local and/or regional PV regulations.
- Maintains oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by PSEQ the Regional PV Teams and/or outsourced partners, in collaboration with Regional PV Leaders who oversee day-to-day operational PV activities.
- **(National QPPV / back-up National QPPV only)** Maintains oversight of AbbVie’s PV System Master File (PSMF) with the authority to ensure that the information contained is an accurate and up-to-date reflection of the PV system.

**Quality Management System**

- Partners with PSEQ the Regional PV Teams to:

- Ensure Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations.
- Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.
- Maintain oversight of the PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with corporate and local PV training requirements.
- Oversee training compliance of partner company staff according to local contract requirements.

**Adverse Event & Periodic Safety Reporting**

- Maintains oversight of the PV system and ensures that processes, procedures and systems are in place for intake, processing, conducting follow up, translation and reconciliation of adverse events and other safety information reportable to PPS GPS from spontaneous and solicited sources as well as from clinical studies.
- Partners with the Regional PV Teams in PSEQ GPS to ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agencies, Ethics Committees and Investigators, in compliance with corporate PV procedures and with local and regional PV regulations as required.

**Audits and Inspections**

- Serves as the Affiliate Lead and point of contact for affiliate PV audits and Regulatory Authority PV inspections, demonstrating understanding of the overall AbbVie PV system and how Global PV processes and PSEQ the GPS Regional PV Teams are set-up and structured, supporting the fulfilment of local legal requirements.
- Collaborates with the GPS PSEQ Regional PV Teams in to manage managing audits of processes executed by the Regional PV Teams and as well as audits of affiliate service providers and third parties.
- Supports PSEQ Collaborates with GPS Regional PV Teams in the development of CAPA in response to observations and the tracksing actions to completion in a timely manner.

**Partnership with business partner with possibility for identification and/or handling of safety information**

- Acts as key safety advisor for affiliate cross-functional partners on safety topics to address business needs and ensure ensuring that business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements, and that applicable PV and safety data exchange agreements are implemented.
- Partners with PSEQ the GPS Regional PV Teams to ensure that:

- All sources of adverse events and other safety information are identified at the local level and mechanisms are in place for collection and collation of all data by PSEQ GPS.
- Content of local Safety Data Exchange Agreements (SDEAs) and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS GPS PV Agreements Database.
- Compliance with local agreements.

**PV Training**

- Collaborates with PSEQ the GPS Regional PV Teams to ensure overall training compliance with corporate procedures and local PV requirements, including the maintenance of the PV Training Matrix and the development of additional PV training materials, as required.

**Legislation Intelligence**

- Collaborates with PSEQ the GPS Regional PV Teams to ensure monitoring of local (and applicable regional/area) PV-relevant hard intelligence, and leads leading the impact assessment of such intelligence them.

**Risk Management**

- Leads the Affiliate Risk Management Team (ARMT) local risk management activities in alignment with local regulations with the Affiliate Medical Director (AMD).
- Coordinates the receipt and distribution of Risk Management Plans (RMPs), Core Implementation Plan Strategy (CIS CIP) and additional risk minimization measures (aRMM) to relevant affiliate stakeholders ARMT members.
- Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products.
- Liaises with ARMT & Benefit Risk Management (BRM) Team the affiliate stakeholders and the Office of Risk Management and where applicable, seek involvement of relevant PSEQ global stakeholders during the development or revision of the local RMP or RMP COUNTRY Specific Annex (if applicable), Local Implementation Plan (LIP) & local or country-specific aRMM.
- Performs the assessment and implementation of the CIS and accompanying aRMM, when applicable.

**Safety Monitoring and Evidence Generation**

- Maintains an overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and maintains awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory agency.
- Be a key driver in the generation and interpretation of safety evidence across the product lifecycle.
- Understands and monitors incoming local safety data and communicate changes or potential concerns to the PSEQ GPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
- Through the oversight of pharmacovigilance processes and the active monitoring of safety data, the ASR ensures that robust evidence is generated to inform risk management, regulatory submissions, and product safety profiles.
- Reviews summary reports of local research-related activities and communicates any safety insights/findings with Medical Teams and PSEQ GPS.
- Leads product safety communication and education initiatives for local cross-functional teams on major PV topics and on local data sources.

**Launch Readiness**

- Sets a solid local safety and PV strategy incorporating proactive PV contributions to ensure a successful product or indication launch at the affiliate.
- Acts as key safety advisor for affiliate cross-functional partners on safety topics.

**PV Advocacy**

- Maintains awareness, oversight and actively contributes to assessing the impact of new legislations on the PV system. Drives AbbVie PV advocacy efforts through strong internal and external collaboration including and engagement with in local trade associations, industry network, and with Regulatory Agencies.
- Collaborates on internal and external PV advocacy efforts, in alignment with the AbbVie, PSEQ GPS, and QPPV Office advocacy guidance.

**After Hours Availability & Business Continuity**

- Ensures that a local Affiliate PV Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV.
- **(National QPPV / back-up National QPPV only)** Ensures availability to be at AbbVie’s disposal permanently and continuously on a 24-hour basis, if applicable, and that an after-hours process is in place for the reporting of AEs and that a Disaster Recovery Plan/Business Continuity Plan is established to allow for continuation of critical business processes for PV.

Qualifications

• Medical, pharmacy or life-sciences degree (or equivalent).

• (National QPPV only) (adjust above accordingly to reﬂect the regulatory requirements for NQPPV

qualiﬁcations)

• At least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is

required.

• (National QPPV only) Adequate theoretical knowledge and practical experience of PV activities and

system under purview (as stipulated in local guidance) and sound understanding of the regulatory and PV

monitoring requirements for assigned territory(ies) that comply with any speciﬁc training requirements

mandated by relevant regulatory agencies.

• Excellent written and spoken communication and presentation skills.

• Fluency in written and oral English is essential to facilitate communications with PSEQGPS, Area/Regional

Medical and other headquarters functions.

• Fluency in written and oral local language is a requirement to facilitate communications within the aﬃliate

medical department, and with the National Regulatory Agency.

• High customer orientation.

• Strong commitment to compliance with the relevant rules and procedures, and to scientiﬁc quality and

integrity.

• Demonstrates strong scientiﬁc acumen and the ability to understand and apply scientiﬁc concepts

eﬀectively.

• Sound judgment, strong planning and organizational skills, and the ability to get things done.

Demonstrated strong sense of urgency

**CRITICAL SUCCESS FACTORS:**

• Builds and maintains strong relationships with aﬃliate stakeholders (e.g. Medical Aﬀairs, Regulatory Aﬀairs,

Commercial) and PSEQGPS.

• Learns fast, grasps the “essence”, ability to manage complexity and changes to change course quickly where

indicated to add value to the PV system.

• Acts consistently with AbbVie’ s ethics, obligations and local laws – putting patient safety, partnerships and

overall AbbVie’s interests before individual, immediate team and functional interests.

• Strengthens the use of product safety knowledge and channels scientiﬁc safety evidence and beneﬁt-risk

information to area and aﬃliate stakeholders to positively impact business strategies.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Eli Lilly and Company

Clinical Research Physician -- Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Purpose:

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct, medical monitoring, and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization. The CRP serves as a scientific resource for study teams, departments, and others as needed.

The Clinical Research Physician must be familiar with, and ensure that all activities and vision of the medical team are aligned and in compliance with, current local and international regulations, laws, guidances (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research.

The primary responsibilities of the Development CRP are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

**1. Clinical Planning**

- Primary responsibility of ongoing clinical trial monitoring. Oversees patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.

- Collaborates with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.

- Contributes to business unit and global alignment of clinical strategy and clinical plans.

- Understands and keeps updated with the pre-clinical and clinical data relevant to the molecule.

**2. Clinical Research/Trial Execution and Support**

- Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed upon project timeline.

- Provides oversight and input into ICDs.

- Collaborates with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).

- Reviews and approves risk profiles to ensure to ensure appropriate communication of risk to study subjects.

- Participates in investigator identification and selection, in conjunction with clinical teams.

- Ensures that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.

- Assists in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.

- Serves as resource to clinical operations personnel/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.

- Understands and actively addresses the scientific information needs of all investigators and personnel events, in alignment with corporate patient safety policies and procedures.

- Reviews IIT proposals and publications, as requested by Director-Medical.

**3. Scientific Data Dissemination/Exchange**

- Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.

- Understands and actively addresses the unsolicited scientific information needs of external health care professionals according to guidelines above.

- Participates in reporting of clinical trial data in Clinical Trial Registry activities.

- Supports the planning of symposia, advisory board meetings, and other meetings with health care professionals.

- Supports medical information associates in preparation and review of medical letters and other medical information materials.

- Prepares or reviews scientific information in response to customer questions or media requests.

- Provides telephone follow-up or specific written information requested by health care professionals as per global SOPs.

- Supports data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).

- Establishes and maintains appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.

- Develops and maintains appropriate collaborations and relationships with relevant professional societies.

- Supports the design of customer research as medical expert.

- Supports training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and global patient outcomes personnel.

- Provides congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).

- Participates in data analysis, development of scientific data dissemination, and preparation of final reports and publications.

**4. Regulatory Support Activities**

- Participates in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.

- Provides medical expertise to regulatory scientists.

- Supports/ assists in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.

- Participates in advisory committees.

- Participates in risk management planning along with affiliates and Global Patient Safety (GPS).

**5. Business/ customer support (core and post-launch support)**

- Contributes to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans personnel and other cross-functional management during the development of the local business plan.

- Understands and anticipates the scientific information needs of all Development customers (payers, patients, health care providers).

- Actively addresses Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts.

- Establishes effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization.

- Establishes and maintains contact with external experts and opinion leaders; maintains a credible scientific expertise to facilitate these contacts.

- Contributes as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.

- Supports business-to-business and business-to-government activities as medical expert.

- Contributes actively on an ongoing basis to the strategic planning for the brand.

- By offering scientific and creative input, contributes to the development, review, and approval of promotional materials and tactics as needed.

- Becomes familiar with market archetypes and potential influence on the medical interventions for the product.

- Takes a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Becomes a patient advocate, as well as a medical expert.

- Participate in PhRMA or other local or national trade associations.

**6. Scientific / Technical Expertise and continued development**

- Critically reads and evaluates the relevant medical literature; knows the status and data from competitive products; and keeps updated with medical and other scientific developments relevant to the product.

- Remains aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5 years).

- Responsible for the scientific training of the clinical study team.

- Acts as scientific consultant and protocol expert for clinical study team members and others in medical.

- Explores and takes advantage of opportunities for extramural scientific experiences.

- Attends scientific symposia.

**7. General Responsibilities**

- Supports the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.

- Actively sets and meets individual professional development goals and contribute to the development of others.

- Actively participates in recruitment, diversity, and retention efforts.

- Collaborates proactively and productively with all alliance, business and vendor partners.

- Participates in active coaching by providing timely and constructive feedback to co-worker, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.

- Participates in committees, Six Sigma initiatives and task forces as requested by local/corporate management.

- Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.

- Models the leadership behaviors.

- Serves as an ambassador for both patients and the Lilly Brand.

**Minimum Qualification Requirements:**

- Medical Doctor or Doctor of Osteopathy. Must be board-eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US-trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board-eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.

- Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see [http://www.in.gov/pla/2799.htm](<https://www.in.gov/pla/professions/medical-physicians-and-osteopathic-physicians-home/medical-licensing-information/#Approved_Disapproved_Foreign_Medical_Schools>)

**Additional Preferences**

- Clinical research experience in Psychiatry or Internal Medicine is strongly preferred.
  - Minimum of 3 years of clinical development experience in an industry setting (or equivalent), including experience with medical monitoring and/or regulatory submissions, or 5 years of clinical research experience in academic setting

- Demonstrated knowledge of drug development process.

- Fluent in English; both written and verbal communications.

- Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills.

- Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.

- Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.

**Additional Information:**

- Primary Location: Indianapolis, US
- A remote/hybrid position can be considered for the right candidate, with travel to Lilly Headquarters at regular intervals and as needed

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$201,000 - $360,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Advisor, Project Information Management & Document Control

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Position Brand Description**

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction and qualification contractors.

Many of the assets delivered focus on manufacturing of medical innovations and delivering innovative solutions to patients. Some of the assets delivered support an expansion in supply of existing medicines.

**Role Summary**

The Advisor, Project Information Management & Document Control serves as the enterprise process owner for project information management, document control, and information governance within Global Facilities Delivery (GFD). The role establishes and governs the standards, processes, systems, and digital delivery requirements used to manage project information across the capital project lifecycle. The Advisor provides strategic leadership for information governance, project information systems, and digital delivery practices, ensuring information quality, consistency, traceability, compliance, and operational readiness across the global portfolio while driving continuous improvement and capability development.

**Key Responsibilities**

- Serve as the enterprise Process Owner for Project Information Management and Document Control, defining governance, standards, procedures, and performance expectations across the global capital project portfolio.
- Own and continuously improve Project Information Management processes governing project documentation, records management, metadata, information lifecycle management, retention requirements, and digital handover.
- Author, maintain, and govern enterprise standards, SOPs, Project Delivery Work Instructions (PDWIs), templates, workflows, and guidance documents supporting consistent information management practices across all projects.
- Establish and govern Owner Information Requirements (OIRs), Common Data Environment (CDE) standards, metadata structures, naming conventions, document classifications, and approval workflows to create a consistent digital ecosystem across internal and external delivery partners.
- Provide governance, assurance, and compliance oversight of Project Information Management practices, conducting assessments, audits, performance reviews, and corrective action programs to ensure adherence to enterprise requirements.
- Serve as business owner for Project Information Management systems and technologies, defining enterprise requirements, governance models, integration strategies, and data stewardship across digital delivery platforms.
- Establish standards and requirements for engineering deliverables, contractor documentation, construction records, commissioning and qualification records, turnover packages, and operational handover information throughout the project lifecycle.
- Define information management requirements for external delivery partners, including A/E, EPCM, Construction Management, and Contractor organizations, ensuring consistent information exchange, document control, digital handover, and compliance with enterprise standards.
- Lead capability-building initiatives for the Project Information Management and Document Control community, providing training, mentoring, guidance, and subject matter expertise to strengthen organizational capability and process adoption. This responsibility aligns with the JD's governance and enterprise ownership focus.
- Drive continuous improvement, digital transformation, and innovation in Project Information Management, evaluating emerging technologies, advancing digital delivery strategies, and implementing improvements that enhance information quality, accessibility, traceability, and lifecycle management.

**Minimum Qualifications**

- Bachelor’s degree in engineering, construction management, or related field, or equivalent experience.
- At least 8 years of experience in engineering, project engineering, information and document control, or similar field.
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1*

**Preferred Qualifications**

- Professional certification in Information Management, Records Management, Project Management, or Digital Delivery (e.g., CRM, IGP, PMP, PMI-CP, AIIM, BuildingSMART, Autodesk Certified Professional).
- Proficiency with Project Information Management and Document Control platforms such as Autodesk Construction Cloud (ACC), Oracle Unifier, Procore, Aconex, SharePoint, and related systems.
- Strong knowledge of information governance, document control, records management, Common Data Environments (CDEs), metadata standards, and digital handover practices.
- Familiarity with industry standards and frameworks, including ISO 19650 and information lifecycle management principles.
- Strong analytical, communication, stakeholder management, and organizational skills, with the ability to drive adoption of enterprise standards and digital transformation initiatives.

**Additional Information**

- Travel is required up to 25%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$130,500 - $211,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Associate Vice President - Early Development Clinical Research Physician - Neuroscience

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Company Overview**

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Purpose and Role**

Lilly is seeking an individual with expertise in early clinical development, including clinical pharmacology, to join a passionate team with a robust, industry-leading pipeline. The ideal candidate will have expertise in neuroscience drug development with demonstrated learning agility, a problem-solving mindset, and the willingness to develop knowledge and skills in new areas. The Clinical Research Physician (CRP) will be the clinical lead to progress multiple early clinical assets into first-in-human studies and support their further development through the conduct of clinical pharmacology and mechanistic studies.

Through the application of scientific and medical training, the CRP participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contacts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders.

The CRP is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. In addition, the CRP works with the basic research scientists to plan pre-clinical studies, develop biomarker plans, and serves as a scientific and medical resource for study teams, departments, and others as needed.

**Basic Qualifications**

- Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.). Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see [PLA: Medical Licensing Information](<https://www.in.gov/pla/professions/medical-physicians-and-osteopathic-physicians-home/medical-licensing-information/#Approved_Disapproved_Foreign_Medical_Schools>) and [Medical Education | MBC](<https://www.mbc.ca.gov/Licensing/Physicians-and-Surgeons/Apply/Physicians-and-Surgeons-License/Medical-Education.aspx>)
- Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
  - U.S. trained physicians must have achieved board eligibility or certification.
  - Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.

- At least ten (10) years of pharmaceutical industry experience, or similar, that provides adequate background relevant to clinical trial design and conduct of first-in-human and biopharmaceutical Phase 1 (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management).

**Additional Skills/Preferences**

- Pharmaceutical company experience preferable.
- Clinical and/or research experience in neuroscience, neurodegeneration, and/or pain research preferable.
- Broad experience in Clinical Pharmacology preferable.
- Experience with genetic therapy modalities (e.g., siRNA, ASO, gene therapy) preferable.
- Additional scientific training or degree (M.S., Ph.D.) preferable.
- Fluent in English; both written and verbal communications.
- Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills.
- Demonstrated ability to influence others (both within teams and a matrix environment) in order to create a positive working environment.
- Ability to engage in domestic and international travel to the degree appropriate to support the business of the team (approximately 10-15%).

**Core Job Responsibilities**

The primary responsibilities of the CRP are generally related to early phase clinical studies and late phase biopharmaceutical submission studies. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.

**_Clinical Planning_**

- Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission.
- Support preparation for first-in-human dosing studies including biomarker plans.
- Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharmaceutical plan to support submission.
- Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies.
- Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug­ disease response models.
- Contribute, as an integral member of the Exploratory Medicine and Pharmacology team, to global Phase 1 clinical studies as well as submission planning activities.
- Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development.
- Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharmaceutical submission plan.

**_Clinical Research/Trial Execution and Support_**

- Design and oversee implementation of all clinical pharmacology studies (e.g., single/multiple ascending dose, bioavailability, bioequivalence, drug-drug-interaction, food effect, renal impairment, hepatic impairment, mechanistic studies). Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations.
- Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research.
- Design and oversee implementation methods for development and biomarker qualification studies.
- Design, create, and provide oversight for protocol development.
- Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements.
- Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements.
- Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group.
- Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects.
- Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
- Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
- Serve as resource to clinical trial managers, clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
- Understand and actively address the scientific information needs of all investigators and personnel.
- Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures.
- Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety.
- Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution.

**_Scientific Data Dissemination/Exchange_**

- Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers.
- Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process.
- Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies.
- Publish results of research projects as appropriate.
- Consider, review, or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects.
- Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology-biopharmaceutical trials.
- Provide clinical reports for local and international regulatory purposes.

**_Regulatory Support Activities_**

- Support and assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response.

**_People Management and Development:_**

- Develop and retain a scientifically excellent, innovation-minded, highly capable workforce with strong exploratory medicine experience.
- Build an organizational culture that fosters inclusion and innovation, continual improvement, and with an external understanding and awareness.
- Develop an organizational talent base that demonstrates judgment-based risk taking and decision making.

**_Business customer support (pre and post launch support)_**

- Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, New Product Planning, and business development.
- Understand the scientific information needs of all Development customers (business unit, payers, patients, health care providers).
- Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.
- Support business-to-business and business-to-government activities as medical expert.
- Contribute actively on an ongoing basis to the strategic planning for the brand.
- Become familiar with market archetypes and potential influence on the medical interventions for the product.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$268,500 - $466,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Advisor/ Sr. Advisor - Regulatory CMC

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The purpose of the Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) –CMC Platform Regulatory Scientist role is to provide strategic, tactical, and operational regulatory CMC support across therapeutic modalities and manufacturing technologies in support of clinical trials, market registrations, and post-approval activities. This role applies CMC technical knowledge and regulatory expertise to develop and execute sound global regulatory strategies, ensuring internal consistency, effective change management, and predictable regulatory outcomes. Success in this role requires building collegial and productive relationships across research, development, development, manufacturing, quality, regulatory, and partner organizations.

\*\*Location: Indianapolis or Boston (hybrid)

**Regulatory & Scientific Expertise**

• Apply strong technical knowledge of CMC drug development and pharmaceutical manufacturing sciences across drug substance, drug product, and analytical areas.

• Demonstrates broad knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials, obtaining global product registrations, and maintaining approved registrations.

• Develops, implements, and maintains global CMC regulatory strategies in response to evolving regulatory expectations and program needs.

• Provides high-quality, timely regulatory advice to enable informed development, manufacturing, and lifecycle planning decisions.

• Evaluates the regulatory impact of proposed CMC development, manufacturing, or change strategies and identifies risks and mitigation options.

• Leads preparation, review, and finalization of CMC documents for global regulatory submissions, including clinical trial applications, marketing applications, variations/supplements, and responses to health authority questions.

• Anticipates and resolves technical or operational issues that could impact submission timing, regulatory compliance, or product supply.

• Independently manages technically challenging or complex issues and proposes practical, risk-based regulatory solutions.

Influence

• Build strong working relationships across Global Regulatory Affairs, research and development, manufacturing, quality, and regional/affiliate regulatory teams to drive alignment on CMC regulatory strategies.

• Provides regulatory guidance and subject matter expertise to CMC teams and stakeholders to support successful submissions and approvals.

• Exhibits strong leadership behaviors and is recognized as a trusted mentor and resource within the regulatory CMC community.

• Incorporates new regulations, guidance, and company positions into processes, tools, templates, and training materials to support consistent execution.

• Provides input into internal policy development and contributes to internal discussions on emerging global CMC regulatory trends.

• Participates in industry forums or working groups, as appropriate, to maintain awareness of evolving regulatory expectations.

**Lead / Partner**

• Leads or supports cross-functional teams in the development and execution of global CMC regulatory strategies.

• Takes an active role in the critical review of CMC development strategies, control strategies, and submission content to ensure regulatory robustness.

• Collaborate effectively with manufacturing sites, technical experts, and quality organizations to resolve regulatory issues and support timely delivery of commitments.

• Supports health authority interactions for CMC topics, including preparation of briefing materials and responses to questions, as appropriate.

• Communicate regulatory strategies, risks, and recommendations clearly and effectively to team members and stakeholders.

• Participates in forums that share regulatory knowledge, lessons learned, and best practices across the organization.

• Contributes to the development of corporate positions and responses to proposed agency regulations and guidelines relevant to CMC.

**Basic Qualifications**

- Bachelor’s degree in sciences discipline (e.g. chemistry, biology, biochemistry, pharmacy or related scientific discipline)
- Minimum of 5 years regulatory CMC experience within pharma or biotech industry

**Additional Preferences**

- 7 + years pharmaceutical industry experience in CMC technical drug development
- Prior experience authoring CMC submission content
- Demonstrated strong written, spoken and presentation communication skills.
- Demonstrated negotiation and influence skills.
- Demonstrated attention to detail.
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$168,000 - $268,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Massachusetts

Director, Regulatory Affairs Business Development

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Director of Regulatory Business Development is responsible for the regulatory scientific assessment, due diligence activity, preparation of development strategy and scenarios, preparation of risk/gap assessment and mitigations, and the preparation of regulatory assessments and recommendations supporting external business development activities. The position is responsible for supporting all aspects of the Business Development and Acquisition strategy that involves Regulatory activities, including: 1) proactively identifying potential new business opportunities, 2) participating and leading cross-functional teams to conduct thorough evaluations of new business opportunities, 3) formulating recommendations and development scenarios related to Regulatory Affairs aspects for executive management consideration, and 4) participating in negotiations and ensuring timely execution of legal agreements with external parties. This role serves as the primary GRS interface with Business Development, Search and Evaluation, Research and Development, Global Manufacturing and Supply Chain and Commercial Development organizations for the purposes of scientific assessment, due diligence activities, development plan generation, financial modeling support, and contract creation and finalization. The Director, Regulatory Business Development ensures business needs are met by anticipating, identifying, prioritizing and communicating regulatory risks, as well as developing R&D scenarios to address and mitigate the risks associated with candidates undergoing evaluation. This role supports regulatory activities associated with business transactions including in-licensing and out-licensing, co-development/collaborations, acquisitions of new chemical or molecular entities including advanced, tissue, and cell-based therapies, platform technologies, marketed products, and company acquisitions to further the company’s overall strategic business development objectives.

- Responsible for preparing oral and written regulatory scientific assessments for potential in-license/out-license, R&D co-development/collaborations and all company or asset acquisitions based on face-to-face and virtual meetings with external companies/representatives, and confidential and public data review for identified compounds, companies, or entities
- Responsible for preparing GRS evaluations and recommendations for venture investment opportunities of new and emerging platform technologies
- Responsible for leading GRS activities supporting the out-license/divestiture of AbbVie development stage compounds or marketed products to external business partners
- Responsible for developing the regulatory strategy and inputs into future development plans, commercialization, and targeted product profiles (or aspirational product concepts) for candidates undergoing evaluation for financial modeling purposes. The evaluation includes a first pass resource need assessment
- Responsible for incorporating and negotiating the regulatory activities, specifications, and requirements that are in alignment with the planned development scenario and deal model/structure within the final contract and agreement
- Responsible for timely delivery and accurate communication, decision making and recommendations for regulatory scientific assessments to all levels of GRS and R&D management and leadership. Directly interacts and communicates with key internal and external stakeholders (see below for examples) across all phases of the business development process (i.e. scientific assessment, due diligence, meetings with company, internal debriefs/decision-making meetings, alliance management meetings)
- Thoroughly understands current global industry and key country/region regulatory environments (e.g., US, EU, Japan, China, etc.), guidelines/guidance and trends, pharmaceutical drug development across multiple therapeutic areas, key global pharmaceutical and health care initiatives, and competitive landscape and intelligence to support the regulatory assessment, identification of regulatory risks and mitigation plans, and recommendations for the identified compounds or companies
- Responsible for seeking or obtaining internal or external consultant resources to provide specialized expertise as needed to support opportunity assessments. Intimately knowledgeable of the broad AbbVie organization and is able to obtain accurate information in efficient manner.
- Manages both indirectly and directly internal regulatory resources and consultants identified with specific needed expertise to support peak activity levels
- Manages regulatory budget and operating expenses associated with due diligence and external consultant spend
- Responsible for development and implementation of standard processes, templates and communication tools to be used for the scientific assessments and reports used to communicate regulatory, quality, and safety risks and recommendations; responsible for program transfer of executed business opportunities within internal Regulatory teams

Qualifications

- Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject
- Preferred Education: Relevant advanced degree is preferred. Certification a plus.
- Required Experience: 7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US & Canada region. Proven 5+ years in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment with multiple stakeholders and influencing cross-functional teams. Experience interfacing with major government regulatory
- Required Experience cont'd: Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies
- Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen. Familiarity with device regulations
- Note: Higher education may compensate for years of experience

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Frederick National Laboratory for Cancer Research

Lab Animal Research Associate I

**Lab Animal Research Associate I**

Job ID: req4718

Employee Type: exempt full-time

Division: Laboratory Animal Science Program

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Laboratory Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of state-of-the-art technologies and services focused on the design, generation, characterization, and application of genetically engineered and biological animal models of human disease. The Animal Research Technical Support (ARTS) team within LASP utilizes advanced methodologies to perform research into the development of new cancer models, targeted diagnostics, and cancer therapies.

**KEY ROLES/RESPONSIBILITIES**

As a Research Associate, you will be working closely with a diverse team in a fast-paced environment on multiple basic and translational cancer research projects simultaneously. Types of studies include tumorigenesis, toxicity, PK/PD, cancer treatment and vaccine efficacy studies on xenograft/allograft, PDX, or genetically engineered mouse models. Responsibilities include taking lead on the in vivo portions of studies from start to finish, including project planning, conducting experiments, recording, and creating detailed study reports, and updates for the investigators. Research Associates coordinate and communicate study details and scheduling with other core facilities, team members, and management. Specific responsibilities include:

- Performing rodent colony management and maintenance of real-time animal colony database (TOPAZ).
- Designing optimal breeding strategies based on genotyping results.
- Independently designing and scheduling experimental studies.
- Performing experiments including surgical procedures utilizing experimental compounds and chemical carcinogens.
- Performing injections via various routes including s.c., i.p., i.v., and oral gavage.
- Monitoring phenotypes and treatment responses.
- Performing detailed necropsy procedures to collect blood and tissues.
- Collecting and recording tumor measurements and body weights utilizing electronic instruments and databases.
- Working with potentially hazardous radiological, chemical, and biological materials.
- This is a change-in facility.

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research or four (4) years equivalent experience in the appropriate field in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to educational requirements, a minimum of two (2) years' job-related biomedical experience.
- Experience in rodent breeding colony management and associated procedures.
- Experience in performing experimental procedures including injections and compound administration.
- Experience working with various tumor models.
- Ability to maintain precise, accurate records utilizing different software platforms.
- Knowledge of standard operating procedures for animal facilities and the basic requirements for maintaining laboratory animals and performing scientific procedures involving animal testing and data collection.
- Ability to obtain and maintain a security clearance.

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- Experience with cancer treatment or vaccine studies in rodents.
- Experience in calculating dosing concentrations and preparing chemicals for dosing.
- Experience in performing surgical procedures on rodents.
- Understanding of Mendelian genetics.
- AALAS certification.
- Excellent time management and organization skills; ability to multi-task and work under time constraints.
- Excellent written and oral communications skills.

**JOB HAZARD**

- This position is subject to atmospheric conditions that would require the usage of a respirator,
  requiring a medical clearance.
- This position is subject to working with or has the potential for exposure to animals and/or animal material(s).
- This position is subject to working with or has the potential for exposure to infectious material,
  requiring medical clearance and immunizations.

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

59,600.00 - 85,400.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Maryland

Senior Auditor, Supplier Audit & Compliance

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

**Purpose**:

Primarily responsible for carrying out comprehensive quality system audits of third-party service providers and manufacturers for compliance with applicable global regulatory requirements. Responsible for providing quality

consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide

**Responsibilities**:

- Carry out job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies.
- Independently plan and conduct external supplier audits assessing compliance of systems, facilities, and processes per applicable regulations and AbbVie specifications.
- Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained.
- Assist in maintaining approved supplier list, global audit schedule and participate in supplier management processes (e.g. Management Review, Supplier Change Notifications, etc.).
- Provide guidance and training on GxP regulations and guidelines to audit team members and internal business partners.
- Assist on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers.
- Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
- Expected to elevate any issues to management, as necessary, in meeting these responsibilities.
- Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight.
- Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
- Collaborate with AbbVie Operations in coordinating and conduct of joint audits.
- Ensures audits are conducted according to the annual audit schedule.

This is an experienced level compliance position that reports to the Director RDQA External Partners Quality Audit or designee. This individual is expected to identify and resolve problems through effective interpersonal skills. The incumbent will work effectively independently or as a team, mentor others, and also be an effective cross-functional team leader. Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas.

Qualifications

- Bachelor’s degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).
- Demonstrated strong leadership competencies, proficient level of technical capabilities, and

independence. Proven track record utilizing core & technical competencies.

- 8+ years’ total experience, including 3+ years in compliance or auditing role.
- Sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries and thorough understanding of international GMP and Device regulatory standards (e.g. US FDA, EU, MDR/IVDR, etc.).
- Quality Assurance auditing experience (preferred)
- Pharmaceutical/Device Manufacturing experience (preferred)
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ)
- Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA))

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Insmed Incorporated

Legal Applications Senior Lead – CLM & Legal Technology

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We are seeking a Legal Applications Senior Lead – CLM & Legal Technology who will be a senior individual contributor and business-facing technology leader focused on serving as the primary Enterprise Applications technology partner for the Legal organization. You will own the ongoing strategy, evolution, and business value of the Legal technology portfolio.This is a senior individual contributor and business-facing technology leadership role focused on serving as the primary Enterprise Applications technology partner for the Legal organization. The successful candidate will own the ongoing strategy, evolution, and business value of the Legal technology portfolio.

**What You'll Do:**

In this role, you’ll have the opportunity to lead the transition, stabilization, adoption, and continuous improvement of the Agiloft Contract Lifecycle Management platform.

You’ll also:

- Drive optimization of contract intake, authoring, review, negotiation, approval, execution, and obligation management workflows.
- Maintain product backlog and roadmap based on business value and operational efficiency.
- Serve as the primary Enterprise Applications partner for Legal leadership and Legal Operations. Develop deep understanding of Legal's processes, priorities, pain points, and operational goals.
- Proactively identify opportunities to simplify and automate work. Explore contract analysis, patent research, privacy automation, regulatory monitoring, and drafting assistance.
- Translate business challenges into technology solutions through prototypes and demonstrations.
- Represent Legal requirements within Guide Path (ServiceNow-based enterprise workflow platform).
- Ensure cohesive experience across Agiloft, Oracle ERP/procurement, and connected systems.
- Partner with Enterprise Architecture on integration patterns and data flows.
- Drive AI-powered capabilities across all Legal practice areas (Contracting, IP, Privacy, SEC compliance).
- Ensure AI implementation aligns with enterprise governance and Legal operational standards.

**Who You Are:**

You have aminimumof a Bachelor's degree in Computer Science, Information Technology, Engineering, or a related field as well as a minimum of 7 years of progressive experience in Enterprise Applications, Legal technology, Legal Operations technology, CLM, business applications, or product management.

You are or also have:

- Strong experience with Agiloft Contract Lifecycle Management platform (highly preferred)
- Demonstrated experience partnering with senior business stakeholders
- Strong business-analysis and product-management skills
- Experience managing enterprise SaaS applications after implementation
- Business Partnership — Builds credibility with Legal leadership as a trusted technology advisor
- Show-Me Mindset — Uses demonstrations, prototypes, and working examples to move conversations forward
- Product Thinking — Treats Legal applications as continuously evolving products
- Systems Thinking — Understands how Agiloft, GuidePath, ERP, and AI capabilities must work together
- Outcome Orientation — Measures success through business improvement rather than number of enhancements delivered

**Nice to have (but not a must):**

- Demonstrated experience with ServiceNow, particularly enterprise workflows as well as with Oracle Fusion ERP or other enterprise ERP/procurement platforms.
- Exposure to AI-enabled Legal technology and workflow automation.
- Proven experience in pharmaceutical, biotechnology, or life sciences (regulated environments).

**WhereYou’llWork**

This is a hybrid role based out of ourBridgewater, NJ office.You’llhave theoptiontowork remotely, with in-person collaboration1-2 days a week when it matters the most.

\#LI-hybrid

\#LI-EG1

**Pay Range:**

$133,000.00-173,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

Compliance Manager, Clinical Supply Chain

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Compliance Manager, Clinical Supply Chain on the Clinical Supply Chain team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Clinical Supply Chain, you’ll be responsible for managing compliance activities throughout the supply chain for assigned studies and projects ranging from phase I to phase IV clinical studies.

**What You'll Do:**

In this role, you’ll have the opportunity to ensure audit readiness for potential inspections to support the Clinical Supply Chain and Technical Operations and serve as main point of contact for compliance within the clinical supply on designated studies and projects function. You’ll also:

- Assist in developing the TMF index to better support the supply chain for assigned studies and/or programs
- Support IRT system design and UAT requirements for assigned studies. Perform UAT testing on IRT systems
- Support Change Control management activities within the clinical supply chain
- Coordinate with and manage external packaging, labeling and distribution vendors
- Represent Supply Chain & Logistics at cross-functional study level meetings to ensure timely updates and information to assigned studies/projects
- Communicate relevant project information to internal and external stakeholders
- Develop and present slide decks, coordinate drafting of reports, and edit documents for preparation of business development activities
- Identify, report, manage and mitigate risks in the clinical supply chain
- Provide regular updates to the TMF as per regulatory requirements
- Understand anernal stakeholders to ensure supply compliance at each node within the supply chain
- Coordinate with Supplier Relationship Management for clinical suppliers, including maintaining key performance metrics
- Coordinate with Insmed contracted clinical supply organizations to appropriately disposition clinical supply material
- Draft SOPs, WPs and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements
- Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results
- Responsible for managing the groups training curriculum

**Who You Are:**

You have a bachelor’s degree along with 5+ years of experience in drug development, clinical supply chain management and/or clinical manufacturing operations.

You are or you also have:

- Ability to identify risks
- in process management and develop a solution-based approach that is operationally achievable
- Proficient with Microsoft Applications (Excel, PowerPoint, Word)
- Experience working with and/or managing external vendors
- Working knowledge of GMP, GCP and ICH guidelines
- Strong teamwork and collaboration skills
- Strong ability to handle multiple projects simultaneously
- Act with a sense of urgency

**Nice to have (but not required):**

- MS Project and other computer software demand & supply related systems are a plus

**Where You’ll Work**

This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most.

**Travel Requirements**

This role requires occasional global travel (approximately 5%–15%)

\#LI-BA

LI-HYBRID

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Research Associate, Gene Therapy

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Research Associate on the San Diego Research and Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Research Gene Therapy, you’ll support gene therapy development through molecular biology, protein analysis, cell culture, sterile technique, and transfection.

**What You'll Do:**

In this role, you’ll have the opportunity to expand molecular and product specific assay development working with the Gene Therapy Research and Development team. You’ll also do:

- Molecular biology (cloning, restriction digests) under the supervision of a senior scientist
- Protein science, including western blot
- Cell culture, sterile technique, and transfection

**Who You Are:**

You have a Bachelor’s degree in biology, chemistry, or related field.

You are or you also have:

- General cellular and molecular biology proficiency (including experience with PCR and Western Blot)
- Excellent communication skills with ability to interact professionally with colleagues and present research results in written reports and team presentations
- Willingness to learn new techniques and train other laboratory staff in technical matters
- Entrepreneurial spirit, with strong willingness to take on new challenges to bring novel medicines to the clinic
- Strict adherence to environmental, health, and safety guidelines

**Nice to have (but not required):**

- Histology, cloning, general mammalian cell culture, transfection and familiarity with in vivo rodent models

**Where You’ll Work**

This role is based out of our San Deigo, CA office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Travel Requirements**

Minimal travel expected

\#LI-ONSITE

\#LI-MC1

**Pay Range:**

$80,000.00-102,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

California

Senior Director, DSPV Quality, Training & Compliance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Senior Director, DSPV Quality, Training & Compliance to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Global Head of DSPV, the Senior Director will be responsible for oversight of the Drug Safety and Pharmacovigilance (DSPV) quality and compliance framework, supporting the ongoing effectiveness, inspection readiness, and regulatory compliance of the PV function.

Through the aggregation and evaluation of compliance information across the PV system, the role supports both the Head of Pharmacovigilance and the EU/UK QPPV in maintaining effective oversight of the PV system and driving continuous improvement. This individual will be a key member of the DSPV Leadership Team and will partner closely with Insmed Quality.

**What You'll Do:**

In this role, you’ll have the opportunity to enable the oversight of PV activities through compliance monitoring, quality event, deviation, and CAPA management, inspection readiness, audit follow-up, procedural governance, training compliance, trend analysis, and management reporting. You’ll also be responsible for:

**Pharmacovigilance Compliance Oversight**

- Maintain and continuously improve the PV compliance monitoring program, providing independent monitoring and governance support to DSPV leadership and the EU/UK QPPV, and ensuring appropriate escalation of significant issues and emerging risks.
- Serve as the primary DSPV liaison to Quality for PV-related compliance and quality system activities, and partner with DSPV Business Process Owners to oversee vendor performance, compliance risks, quality events, and remediation.

**PV System Monitoring**

- Establish and govern DSPV standards for compliance monitoring, KPIs, and quality metrics; aggregate and analyze Business Process Owner metrics; and oversee quality and compliance dashboards.
- Trend performance, deviations, CAPAs, audit findings, inspection observations, and other quality indicators to identify recurring issues and systemic risks and communicate insights on PV system effectiveness to DSPV leadership and governance forums.

**Training and Procedural Governance**

- Own the DSPV training framework, curricula governance, competency development, and training compliance program, partnering with Business Process Owners, HR, and DSPV leadership to support capability building, professional development, and role-based learning.
- Oversee the lifecycle of DSPV standards, SOPs, work instructions, and controlled documents, including development, review, approval, periodic review, version control, and archival; partner with Business Process Owners to ensure procedures, training, and performance measures remain compliant, harmonized, effective, and aligned with DSPV standards.

**Audit and Inspection Readiness**

- Partner with Quality to coordinate DSPV preparation and participation in regulatory inspections, audits, and due diligence assessments.
- Lead tracking of audit findings, inspection observations, and associated CAPA plans, and analyze outcomes to identify trends, improvement opportunities, and compliance risks.

**Quality Event, Deviation, and CAPA Management**

- Partner with Quality to ensure effective management of PV-related quality events, deviations, and CAPAs, including those arising from audits and inspections.
- Facilitate root cause analysis and preventive action development and trend quality events and CAPAs to identify recurring issues and systemic process weaknesses.

**Continuous Improvement**

- Collaborate with Quality to strengthen PV compliance and inspection readiness, recommend improvements to process compliance, governance, and monitoring, and promote a culture of quality, accountability, and continuous improvement.
- Partner with the EU/UK QPPV Office and Regulatory Intelligence sources to independently oversee DSPV Business Process Owners’ assessment, implementation, and effectiveness monitoring of regulatory-driven changes impacting DSPV.

**Who You Are:**

You must have a Bachelor’s degree in a life sciences discipline and 10+ years of experience in pharmacovigilance. Additionally, you have:

- 3+ years of experience in a quality or compliance leadership role.

- Demonstrated experience managing global pharmacovigilance inspections conducted by major health authorities.

- Deep knowledge of global PV regulations and guidelines (FDA, EMA, ICH).

- Strong track record of building and leading teams in a fast-paced, dynamic environment.

- Experience in a small or mid-size biopharma environment.

**Nice to Have (but not required):**

- Advanced degree (MS, PharmD, PhD) strongly preferred.

- Experience in both clinical and commercial stage environments preferred.

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to yourInsmedteam and community.Occasional travel for team meetings or eventswillbe expected.

**Travel Requirements**

This position involves occasional domestic travel for face-to-face Leadership Team meetings (approximately 5-10%).

\#LI-Remote

\#LI-MM

**Pay Range:**

$222,000.00-303,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

Nationwide

Summer Intern - Biologics Research

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Summer Intern - Biologics Research on the Research Team to help us expand what’s possible for patients with serious diseases.

The Insmed Summer Internship Program is designed to give you more than just a glimpse into the pharmaceutical industry—it’s a chance to make a real impact. Over the course of the summer, you’ll gain hands-on experience, contribute to meaningful team projects, and learn directly from skilled professionals who are invested in your growth.

Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship. The internship may present opportunities for rotational assignments within the function, and the intern will be assigned goals and objectives that will support the strategic business plan of the company.

**What You'll Do:**

In this role, you’ll have the opportunity to contribute directly to the discovery and early-stage development of cutting-edge biotherapeutic candidates — helping advance science that could one day transform the lives of patients living with serious diseases.

You'll also:

- Assist with protein characterization, including biophysical assays and stability assessments
- Perform cloning and expression protocols towards the development of a biotherapeutic candidate.
- Work in concert to evaluate and contextualize experimental results.
- Accurately keep records of experimental work flows.

**Who You Are:**

You are a current student working on a Masters degree or PhD in Molecular Biology, Biochemistry, Protein Engineering (or related field).

You are or you have:

- Experience with molecular biology and cloning techniques.
- Experience with candidate screening.
- Experience with or knowledge of the expression and purification of recombinant proteins.
- The ability to conduct accurate and well executed experiments with sufficient documentation.

**Nice to have (but not required):**

- You have experience with the development of novel assays and screening procedures.
- You have other experiences in the biotech industry

**Where You’ll Work**

This role is based out of our Lebanon, New Hampshire lab and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Pay Range:**

$20.00-35.00 Hourly

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. Our internship program reflects that commitment by supporting how you learn, grow, and show up each day while contributing to work that matters.

Our internship offerings include:

- Paid company holidays
- Hands-on learning in real-world projects
- Networking opportunities with leaders and social events with your peers
- Mentorship and professional development
- A final presentation to celebrate your contributions
- Access to office amenities for those who are not remote

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

New Hampshire

Research Associate I, Gene Editing

**Research Associate I, Gene Editing**

Job ID: req4720

Employee Type: exempt full-time

Division: Laboratory Animal Science Program

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Laboratory & Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for laboratory and animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of husbandry, veterinary, state-of-the-art technology, and pre-clinical scientific services.

**KEY ROLES/RESPONSIBILITIES**

- Design and build reagents for gene editing experiments
- Testing gene editing reagents in cultured cells
- Isolating nucleic acids from edited culture cells and performing downstream molecular biology assays (e.g. quantitative polymerase chain reaction (PCR))
- Preparing DNA input for high throughput Illumina sequencing
- Analysis and interpretation of results from gene editing experiments

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to education requirements, a minimum of two (2) years of experience in laboratory molecular biology
- Experience in maintaining and manipulating cultured cells using sterile techniques
- Experience in designing and performing PCR experiments
- Experience with meticulous note-taking to maintain accurate and precise records
- Ability to obtain and maintain a security clearance

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- Gene editing (Zinc finger nucleases, TALENs, or CRISPR technologies)
- Illumina sequencing – preparing DNA sequencing libraries
- Plasmid DNA cloning
- Excellent written and oral communications skills – primary author publications and/or oral presentations

**JOB HAZARDS**

- This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

59,600.00 - 85,400.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Nurix Therapeutics

Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)

**Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)**

*Shape the CMC regulatory path for Nurix's small molecule portfolio, from clinical development through marketed lifecycle. You'll combine hands-on authoring of Module 3 (Quality) content with real strategic influence as the CMC regulatory voice on cross-functional teams, with room at the Associate Director level to own strategy and mentor junior regulatory staff.*

**Position Description**

**The Opportunity**

- Report to the Senior Director, Regulatory Affairs CMC (Head of Regulatory CMC, Small Molecules) as a key member of the Regulatory Affairs team
- Develop, communicate, and execute global CMC regulatory strategies for assigned programs (drug substance and drug product) across the product lifecycle
- Author, review, and compile high-quality CMC (Module 3 / Quality) content for regulatory submissions, including IND/IMPD and equivalent global filings, amendments, annual reports, and responses to health authority questions
- Assess the regulatory impact of manufacturing, analytical, formulation, and supply chain changes, and recommend filing strategies and categorization (e.g., substantial, non-substantial, annual reportable)
- Provide proactive CMC regulatory guidance and risk assessment to development, technical operations, and commercial teams
- Partner with Technical Operations/Manufacturing, Analytical Development, Quality Control, Quality Assurance, Supply Chain, and CMOs/CDMOs (where applicable) to align technical activities with regulatory requirements
- Represent CMC Regulatory on project and CMC sub-teams, and manage submission timelines and deliverables in coordination with regulatory operations and publishing
- Ensure submission content is accurate, consistent, scientifically sound, and compliant with ICH guidelines and regional requirements (FDA, EMA, and other markets relevant to the portfolio)
- Contribute to regulatory intelligence by monitoring evolving guidance and precedent and translating it into practical advice
- Oversee quality assurance processes to ensure compliance with regulatory standards, and participate in cross-functional initiatives that improve regulatory submission processes and systems
- At the Associate Director level, take greater strategic ownership and, where applicable, provide line management or mentoring of junior regulatory staff

**What You’ll Bring**

- Bachelor's degree in chemistry, pharmacy, pharmaceutical sciences, chemical engineering, or a related life sciences field is required; an advanced degree (M.S., Ph.D., or Pharm.D.) is preferred
- Minimum 6+ years in regulatory affairs with a substantial focus on CMC, and 10+ years of overall pharmaceutical/biotech industry experience
- Demonstrated experience authoring and/or compiling CMC (Module 3) content for regulatory submissions for small molecule products
- Working knowledge of ICH quality guidelines and of FDA and/or EMA CMC requirements; familiarity with other global regions is a plus
- Solid understanding of pharmaceutical development, manufacturing processes, and analytical methods for small molecules
- Strong written communication and scientific/technical writing skills
- Ability to manage multiple projects and competing timelines with attention to detail
- Effective cross-functional collaboration and stakeholder management
- Comfort operating with autonomy while escalating appropriately

**Salary Range:**  $187,800 - $208,600

*The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.*

**Location:** Onsite – Brisbane, CA

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**About Nurix Therapeutics**

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

Jazz Pharmaceuticals, Inc.

Director, Compliance Business Partner

**If you are a current Jazz employee please apply via the Internal Career site.**

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit [www.jazzpharmaceuticals.com](<https://www.jazzpharmaceuticals.com>) for more information.

**Primary Responsibilities**

- Advise Global and US business colleagues on various initiatives in a way that advances the company’s strategy while addressing legal and compliance risks and protecting the company’s integrity and reputation.

- Provides day-to-day strategic and tactical compliance guidance to leadership and cross-functional teams to drive fact and risk-based decision making

- Identifies and develops compliance tools and resources to help business functions to apply compliance principles and enable ethical decision making.

- Develops and maintains strong working relationships with business function management and participates in their leadership meetings to ensure potential compliance risks are proactively identified, discussed, and mitigated.

- Develop and maintain strong relationships and collaborate frequently with Legal, Human Resources, Internal Audit, and colleagues in other functional areas both in and outside of the US.

- Partners with compliance colleagues to identify observations and trends to incorporate into monitoring/audit protocols, policy and SOP updates, Compliance training, and relevant Compliance communications.

- Liaises between Compliance Operations and business functions to provide and support coaching, training, and/or discussion with business function managers and/or leaders.

- Maintain a high level of knowledge of current and emerging laws, regulations, codes, and recent enforcement actions across the US and inform and educate business colleagues with tailored communications.

- Support continuous improvement of the Global Compliance Program including risk assessments and remediation

- Assesses compliance training needs for the business function and develops and delivers ad-hoc training as needed.

- Reviews and provides input as a subject matter expert to the business during the review and update of policies and SOPs.

- Develops and maintains updated knowledge and understanding of Jazz’s products, industry regulations and guidelines, and Company policies and standard operating procedures.

- · As required, may be asked to temporarily support other compliance-related activities (e.g. policy updates, monitoring, compliance investigation(s), etc.)

**Required Knowledge, Skills, and Experience**

- Minimum of 10 years of healthcare compliance experience with a pharmaceutical/biotechnology company or within the life sciences industry required.
- Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically PhRMA Code on Interactions with Healthcare Professionals required.
- Strong leadership and interpersonal skills to influence without authority, work collaboratively and pragmatically cross-functionally
- Ability to foster a speak-up and strong internal compliance culture by working as a strategic, trusted business partner
- Excellent written, verbal and presentation communication skills to effectively communicate with all levels of the organization
- Demonstrated experience taking ownership of issues and providing timely, practical, and actionable guidance
- Strong analytical, organizational, and problem-solving skills
- Excellent project management skills with the ability to manage multiple priorities simultaneously, on a timely basis with strong attention to detail, and ability to organize and analyze complex information and data
- Self-starter with demonstrated leadership skills and ability to meet goals; able to exercise sound judgment on complex compliance matters
- Demonstrated superior ability to proactively identify areas for improvement in controls, systems, and processes and implement effective solutions.
- Position is remote based (US) with travel requirements
- Flexibility to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude
- Embraces continuous learning and stays informed on advances in technology, AI and other industry trends

**Required Education**

- Bachelor’s degree required. Advanced degree (masters or JD) preferred

**Description of Physical Demands**

- Position requires ad-hoc travel within the United States (estimated at ~20% per year) for participation at regular business function meetings and activities.

**Description of Work Environment**

- Work indoors will be in a normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes
- Frequent computer use

\#LI-Remote

"

*Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.*

**FOR US BASED CANDIDATES ONLY**

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $189,600.00 - $284,400.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: [https://careers.jazzpharma.com/benefits.html](<https://careers.jazzpharma.com/benefits.html>).

Associate Director, Research Biostatistics

The Associate Director, Research Biostatistics provides strategic and scientific statistical leadership across CSL Research programs and translational science initiatives, partnering with multidisciplinary teams to design studies, analyse complex research datasets, and generate decision-relevant evidence that supports project and portfolio progression. The role remains hands-on, contributing directly to study design, statistical analysis, innovative methodology development, and evidence-generation strategies that support scientific and portfolio decision-making across discovery, translational, and early research programs.

**Key Responsibilities**

- Provide strategic statistical leadership and methodological oversight across discovery, translational, and early research programs, ensuring robust study design, analysis, interpretation, and project decision support.
- Lead and perform complex statistical analyses across preclinical, translational, biomarker, imaging, omics, and human research datasets using advanced methodologies such as Bayesian methods, causal inference, longitudinal modelling, and machine learning.
- Develop and apply innovative statistical methods, reproducible analytical workflows, and statistical programming solutions, particularly in R and related platforms.
- Support biomarker identification, evaluation, and validation activities, contributing to translational evidence-generation strategies that strengthen research and portfolio decisions.
- Translate complex scientific data into actionable insights that support target evaluation, candidate selection, project progression, portfolio prioritisation, and probability-of-success assessments.
- Collaborate with Translational Bioinformatics, Global Biometrics, Data Management, PK/PD, and other quantitative functions, applying state-of-the-art statistical methodologies to address scientific challenges.
- Contribute to scientific publications, ethics submissions, external collaborations, and scientific communications.
- Mentor and develop statisticians, scientists, contractors, and interns, providing scientific leadership and fostering a culture of excellence, collaboration, and continuous learning.
- Champion data-driven decision making, promote statistical best practices, and deliver training to strengthen analytical capability across the organisation.
- Establish and manage relationships with external collaborators, academic partners, CROs, consultants, and technology providers, ensuring delivery of high-quality scientific outcomes.

**Your Profile**

- PhD in Statistics, Biostatistics, or equivalent experience.
- 8+ years of experience applying statistics in a pre-clinical pharmaceutical, biotechnology, healthcare, or biomedical research environment, supporting discovery, translational, biomarker, or early development programs.
- Demonstrated track record in developing and applying advanced statistical methodologies for biological, translational, biomarker, omics, imaging, or related scientific data.
- Proven experience with modern statistical programming, reproducible analysis workflows, and quantitative computing platforms, particularly R and related technologies.
- Evidence of scientific contribution through publications, conference presentations, methodological innovations, or development of analytical tools and platforms.

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.csl.com/careers/your-well-being>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).