Regulatory

Eli Lilly and Company

Director, Global Regulatory Affairs – CMC, Lifecycle Innovation

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 Director, GRA-CMCD Lifecycle Innovation provides scientific, strategic, tactical and operational regulatory leadership for post-approval CMC activities across Lilly's parenteral product commercial portfolio. This role leads complex global lifecycle regulatory strategies across products and manufacturing sites, enabling high-quality, timely execution of post-approval changes while improving submission efficiency and simplifying regulatory processes.

This is accomplished with a strong working knowledge of global regulations, guidelines, and regulatory precedence, coupled with a strong technical knowledge of development, technology transfers and manufacturing processes. The Director develops collegial and mutually productive relationships with regulatory peers, across Lilly components, partner company components, and global regulatory agency personnel — partnering closely with sites and cross-functional teams to ensure high-quality, timely execution of post-approval regulatory activities.

**Key Responsibilities**

- Deep technical knowledge and understanding of CMC molecule drug development and manufacturing science(s); broad technical knowledge of global CMC regulatory requirements and guidelines for reporting post-approval changes and updating global product registrations.
- Provide high-quality, timely, and decisive regulatory advice to allow project teams to make well-informed decisions on product lifecycle planning; anticipate and resolve technical or operational issues that could impact submission timing.
- Serve as regulatory lead for site additions and technology transfers, managing regulatory relationships with Lilly sites and external contract manufacturing organizations (CMOs) to ensure alignment on data packages and submission timelines.
- Develop and implement post-approval regulatory strategies for assigned products and sites, defining filing approaches and data expectations for site changes, analytical updates, specification changes, site additions, and related lifecycle activities.
- Lead preparation, review, and execution of variations, supplements, annual reports, DMFs, and related submissions; review and approve CMC documents for global submissions, including manufacturing changes, annual reports, and renewals.
- Lead regulatory assessments for change controls and deviations for assigned products/sites, applying risk-based principles to categorize and prioritize post-approval changes.
- Work closely with Manufacturing and Quality to develop compliant and scientifically sound data packages; coordinate with sites to ensure readiness and alignment on regulatory expectations and timelines.
- Monitor emerging regulatory guidance related to lifecycle management and apply it strategically to current and future submissions; identify opportunities to simplify lifecycle processes or accelerate submissions.
- Network with GRA, M&Q, and Business Unit leadership, as appropriate, to build awareness and alignment on complex CMC regulatory strategies; serve as a regulatory point of contact for assigned manufacturing sites.
- Contribute to implementation of digital tools supporting lifecycle management, including automated templates, digital submissions, and AI/ML applications. Experience or interest in digital enablement and process simplification is especially valued in this role.
- Communicate lifecycle strategies, risks, and timelines clearly to sites and cross-functional partners; translate regulatory implications for operational and business stakeholders.
- Supervision and/or mentoring of global regulatory affairs scientists, regulatory associates and teams as needed.

**Basic Qualifications/Requirements**

- B.S. degree in a STEM field.
- 10+ years of Regulatory CMC or technical CMC experience supporting post-approval lifecycle management of biologics, parenteral products, combination products, or related complex modalities.

**Additional Skills/Preferences**

- Advanced degree (MSc, PharmD, or PhD) in chemistry, biology, biochemistry, pharmacy, or a related scientific discipline preferred.
- Candidates with broader CMC lifecycle experience across modalities are encouraged to apply.
- Experience developing regulatory strategies, determining submission data packages, authoring CMC submission content for biologic and/or parenteral products and leading teams to deliver timely submissions.
- Experience with marketing authorization application or post-approval change processes including response to questions.
- Knowledge of major global regulatory procedures, regulations, and evolving expectations for post-approval lifecycle management, including change control, comparability, deviation assessments, and post-approval filings.
- Relevant experience across CMC modalities relevant to Lilly's commercial portfolio (e.g., biologics, synthetic peptides, combination products, or other complex modalities), including drug substance, drug product, and analytical sciences considerations.
- Experience with aseptic/sterile manufacturing processes, container closure integrity, and sterility assurance for parenteral drug products.
- Extensive regulatory experience managing complex submission strategies, or equivalent combination of technical and regulatory expertise.
- Experience planning for and participating in Health Authority interactions.
- Demonstrated ability to assess and manage risk in a highly regulated and evolving lifecycle environment.
- Strong written, verbal, and presentation communication skills.
- Demonstrated leadership, with strong influencing and negotiation skills.
- High attention to detail and commitment to quality.
- Strong collaboration skills, with the ability to work effectively across diverse, cross-functional teams and multiple sites or CMOs.

**Additional Information**

- Position Location: Indianapolis, IN. This is not a remote position. Relocation assistance is provided.
- Travel: minimal within the US

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

$177,000 - $281,600

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

Director - Clinical Pharmacologist/Clinical Research Physician

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 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 Cardiometabolic, Immunology or Neurological 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 clinician to progress multiple early clinical assets into first-in-human studies or 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, contracts 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.

**Additional Skills/Preferences**

- At least two (2) years of pharmaceutical industry experience, or similar, that provides adequate background relevant to clinical trial design and conduct of Phase 1 and Phase 2 studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management).
- Pharmaceutical company experience preferable.
- Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research preferable.
- Experience in Clinical Pharmacology 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 and 2 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

$201,000 - $393,800

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

AVP, Asst General Counsel, Global Regulatory Legal

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.

**Associate Vice President, Assistant General Counsel, Global Regulatory Legal**

**Organization 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 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.

The Associate Vice President, Assistant General Counsel – Global Regulatory Legal is a senior regulatory attorney and strategic regulatory partner within the Regulatory Legal Team (RLT). The ideal candidate brings deep regulatory legal expertise and the leadership presence to influence across a complex, matrixed organization. RLT is a core strategic partner to the business, providing regulatory legal counsel across the product lifecycle from development through registration, commercialization, and post-market activities. RLT works in close coordination with other legal and risk functions to deliver cohesive, forward-looking guidance that enables innovation while managing legal and regulatory risk.

**Key Responsibilities**

The primary responsibility of this position is to provide strategic, solutions-oriented legal counsel across a broad regulatory legal portfolio including drugs, devices, and diagnostics. This role requires deep hands-on legal expertise and the ability to build credibility and influence across a complex, matrixed organization. Key responsibilities include but are not limited to:

- Serve as legal counsel to Global Regulatory Affairs (GRA), providing strategic and forward-looking legal guidance across the global product lifecycle — from registration through post-market risk management — for pharmaceutical and medical device products.
- Drive legal advice on FDA regulatory engagement strategy, including pre-submission meetings, information request responses, and enforcement-related interactions, while supporting regulatory submissions to other global health authorities as needed.
- Advise on regulatory strategy for acquisitions, in-licensing, and asset transfers, including regulatory due diligence and post-close integration of assets.
- Integrate regulatory, litigation, and enforcement risk perspectives into legal advice, working closely with the Business Unit Legal Team, Product Development Legal, International Business Unit Legal, IP, Litigation, and other colleagues to anticipate and mitigate emerging risks.
- Monitor and interpret evolving global regulatory laws, guidance, and enforcement trends; proactively translate developments into strategic recommendations for leadership and other internal stakeholders.
- Represent Lilly’s regulatory legal interests in industry forums, trade associations, and regulatory policy initiatives in coordination with Policy, Legal, and other colleagues, including drafting and coordinating responses to regulatory agency requests for public comment on proposed rules and guidance.

**Basic Requirements**

- Bachelor’s degree and Juris Doctor (or equivalent)
- Licensed to practice law in at least one US jurisdiction
- Minimum 10 years of overall experience in a law firm or as an in-house lawyer in a pharmaceutical or life sciences company, with primary focus on pharmaceutical regulatory law
- Broad regulatory legal subject matter expertise spanning the product lifecycle and experience engaging with relevant global health authorities
- Proven ability to manage a substantive and complex legal portfolio independently
- Strong judgment and the ability to navigate complex, novel legal issues across multiple regulatory domains with a solutions-oriented, business-enabling approach
- Enterprise mindset — proactively identifies cross-functional and organizational implications of legal and regulatory issues, balancing deep functional expertise with broader business priorities
- Highly motivated, dynamic, and collaborative partner with a proven track record of building trusted relationships across all levels of the organization, including senior leadership
- Excellent written and verbal communication skills, with the ability to translate complex regulatory legal issues into clear, actionable guidance
- Demonstrated ability to appropriately handle highly confidential and privileged information

**Additional Skills/Preferences**

- Prior regulatory agency experience (e.g., FDA, EMA, or comparable national authority)
- Experience supporting regulatory due diligence in M&A or business development transactions
- Familiarity with environmental regulatory frameworks relevant to pharmaceutical manufacturing
- Experience with medical device or drug-device combination product regulatory matters
- Experience advising on AI/automation governance in a regulated industry context
- Demonstrated effectiveness leading through influence in a matrixed, global organization
- Prior mentoring or leadership experience, with willingness to take on formal people leadership responsibilities in the future should the role evolve in that direction

**Other Information**

- This position may be based at Lilly’s corporate headquarters in Indianapolis, Indiana, or performed remotely.
- Ability to travel 10–15%, including travel to Lilly’s corporate headquarters in Indianapolis, Indiana if based remotely.

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

$229,500 - $336,600

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

Clinical Research Physician - Clinical 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.

**Company Overview**

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

**Purpose:**

This CRP role within the Immunology gastroenterology therapeutic area will support early and late phase clinical trials for assets in the gastroenterology pipeline. 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 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 Clinical Research Physician serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Physician must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance's (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 and activities are aligned with the medical vision.

**Primary Responsibilities:**

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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.

Clinical Planning

- Collaborate 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.
- Contribute to business unit and global alignment of clinical strategy and clinical plans.
- Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.

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 (e.g., annual reports) according to the agreed upon project timeline.
- Provide protocol oversight and input into informed consent documents.
- Collaborate 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).
- Review and approve risk profiles to ensure to ensure appropriate communication of risk to study subjects.
- Participate in investigator identification and selection, in conjunction with clinical teams.
- Ensure 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.
- 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 operations/CTMs/ 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 corporate patient safety policies and procedures.
- Review lIT proposals and publications, as requested by Director-Medical.

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.
- Understand and address the unsolicited scientific information needs of external health care professionals according to guidelines above.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Support medical information associates in preparation and review of medical letters and other medical information materials.
- Prepare or review scientific information in response to customer questions or media requests
- Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
- Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
- Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Support the design of customer research as medical expert
- Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.
- Provide 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)
- Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.

Regulatory Support Activities

- Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
- Provide medical expertise to regulatory scientists.
- Support/assist 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.
- Participate in advisory committees.
- Participate in risk management planning along with affiliates and Global Patient Safety (GPS).

Business/ customer support (ore and post launch support)

- Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans manager/project management associates and other cross-functional management during the development of the local business plan.
- Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers).
- Actively address 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.
- Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization.
- Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.
- Contribute 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.
- 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.
- By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed.
- Become familiar with market archetypes and potential influence on the medical interventions for the product.
- Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert.
- Participate in PhRMA or other local or national trade associations as appropriate.

Scientific I Technical Expertise and continued development

- Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product
- Be 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.
- Explore and take advantage of opportunities for extramural scientific experiences
- Attend scientific symposia

General Responsibilities

- Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.
- Actively set and meet individual professional development goals and contribute to the development of others.
- Actively participate in recruitment, diversity and retention efforts.
- Collaborate proactively and productively with all alliance, business and vendor partners.
- Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
- Participate 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.
- Model the leadership behaviors
- Be an ambassador of 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 [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>)

**Preferred Qualifications:**

- Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
- Demonstrated strong communication, interpersonal, teamwork, organizational, 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.
- Fluent in English, verbal and written communication

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

$198,000 - $356,400

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

Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform

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.

This role provides strategic, tactical, and operational regulatory CMC leadership across advanced therapeutic modalities and manufacturing technologies to accelerate development of the synthetic peptides and oligonucleotide portfolio, supporting clinical trial applications, market registrations, and post-approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory precedent, coupled with deep technical expertise in CMC development and manufacturing processes specific to synthetic peptides and oligonucleotides.

**Key Responsibilities**

- Deep technical knowledge of synthetic peptide and oligonucleotide CMC drug development and manufacturing sciences across modalities and platforms, including drug substance, drug product, and analytical sciences (e.g., solid-phase synthesis, purification, conjugation, characterization, and control strategies).
- Knowledge of global CMC regulatory requirements and guidelines for synthetic peptides and oligonucleotides to support clinical development, global product registrations, and lifecycle management of approved products.
- Development and implementation of innovative regulatory strategies and platform-based approaches, incorporating evolving external expectations (e.g., emerging guidance, novel modality considerations, and regulatory precedent).
- Provide regulatory guidance enabling CMC development teams to make well-informed decisions on development strategies and lifecycle planning.
- Lead preparation, critical review, and approval of CMC documentation for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and responses to health authority queries.
- Take a proactive leadership role in the critical review of molecule-specific CMC development and lifecycle strategies, including considerations unique to peptides and oligonucleotides (e.g., impurity profiles, sequence-related variants, delivery systems, and stability).
- Provide high-quality, timely, and clear regulatory advice to support project teams in advancing complex modalities.
- Make decisions on CMC regulatory strategies impacting global submissions, ensuring alignment across geographies, teams, and platform approaches.

**Basic Qualifications/Requirements**

- B.S. degree in a science, engineering, or related STEM field (advanced degree preferred), such as Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biochemistry, Molecular Biology, or similar.
- 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides, oligonucleotides, or related complex modalities. Candidates with broader experience in advanced modalities are encouraged to apply.

**Additional Skills/Preferences**

- Experience authoring CMC submission content for peptides and/or oligonucleotides, including participation in clinical trial and marketing authorization applications and responses to regulatory questions.
- Knowledge of major global regulatory procedures, regulations, and evolving expectations for complex modalities, including platform technologies.
- Relevant experience in peptide and/or oligonucleotide drug substance and/or drug product development, manufacturing, and commercialization.
- Demonstrated understanding of key development considerations for peptides and oligonucleotides (e.g., synthesis scalability, impurity control, analytical characterization, stability, and delivery systems such as conjugates or lipid-based formulations).
- Extensive regulatory experience managing complex submission strategies or equivalent combination of technical and regulatory expertise.
- Experience planning for and participating in Health Authority interactions.
- Demonstrated ability to assess and manage risk in a highly regulated and evolving modality space.
- Strong written, verbal, and presentation communication skills.
- Demonstrated leadership, with strong influencing and negotiation skills.
- High attention to detail and commitment to quality.
- Strong collaboration skills with ability to work effectively across diverse, cross-functional teams.

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

$148,500 - $257,400

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

Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform

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 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.

This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio and to support clinical trial applications, market registrations, and post approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory precedent coupled with deep technical knowledge of CMC development and manufacturing processes.

**Key Responsibilities**

- Deep technical knowledge of small molecule CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).
- Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations and maintaining approved registrations.
- Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment (new guidance, evolving expectations, and regulatory precedent).
- Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning.
- Leads preparation, critical review, and approval of CMC documents for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and health authority information requests.
- Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies.
- Provides high quality, timely and clear regulatory advice to allow project teams to make well-informed decisions on development or product lifecycle planning.
- Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.

**Basic Qualifications/Requirements**

- B.S. degree in a science, engineering, or a STEM related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
- 10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules. Those with greater than ten years of experience are encouraged to apply.

**Additional Skills/Preferences**

- Experience authoring CMC submission content, and involvement in clinical trial applications/marketing authorization application processes including response to questions.
- Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives.
- Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.
- Demonstrated deep knowledge of the synthetic molecule drug development process.
- Extensive prior regulatory experience handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.
- Experience planning for and participating in Health Authority meetings.
- Demonstrated ability to assess and manage risk in a highly regulated environment.
- Demonstrated strong written, spoken and presentation communication skills.
- Demonstrated leadership behaviors and negotiation and influence skills.
- Demonstrated attention to detail.
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

**Additional Information**

- Position Location: Indianapolis, IN. A remote option may be considered. Relocation assistance is provided.
- Travel: minimal within the US

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$148,500 - $257,400

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

Associate Director - Global Regulatory Affairs - Product Communications

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.

**Organization Overview:**

The purpose of the Associate Director, Global Regulatory Affairs - Product Communications role is to provide leadership and influence to deliver accurate, balanced, and substantiated product and disease communications for assigned assets. The Associate Director partners with Regulatory Scientists, across Lilly brand teams, partner companies, and FDA Office of Prescription Drug Promotion (OPDP) to advise on regulatory requirements and expectations for compliant communications.

**Responsibilities:**

Within the role, the Associate Director will have the responsibility to provide regulatory guidance in the following areas:

**Review of Promotional Tactics and Communication**

- Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics, internal field-based communications, medical affairs communications, and campaign tactics for media events
- Provide high quality, prompt and conclusive regulatory advice that enables business partners to make well-informed decisions
- Communicate regulator expectations by utilizing OPDP feedback received by Lilly, interpretation of applicable laws, regulations and guidances, and knowledge of FDA enforcement actions.
- Contribute to business risk mitigation strategies by following trends in external environment related to advertising, promotion and medical communication topics
- Build, maintain, and utilize relationships with Lilly team members and partner companies, as appropriate, to effectively influence the implementation of appropriate communications.
- Initiate promotional tactic discontinuation plans for Regulatory-initiated events

**Facilitate Interaction with FDA OPDP**

- Counsel internal partners on OPDP advisory strategy; collaborate with marketing and advertising agency in development of promotional proposals, and provide quality review of submission documents
- Partner with US brand team to interpret OPDP advice and support any interactions with OPDP
- Provide a well-timed and quality review of 2253 promotional material submissions to FDA

**Collaborate with Other Regulatory colleagues**

- Engage US Regulatory Scientist in 1) development and analysis of promotional claims and suggest marketing on promotional strategy and 2) review of press materials and IR communications.
- Work closely with US Regulatory Scientist and Labeling Operations to lead labeling revisions to balance consideration of business implication and regulatory compliance
- Communicate and share key information to enable seamless execution of US regulatory strategy and promotional activity

**Lead/Influence/Partner**

- Engage in forums that share regulatory information across the organization, other Lilly teams, and business partners
- Constructively challenge teams to reach the best solutions to issues
- Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions

**Minimum Qualifications Requirements:**

- Bachelor's Degree
- 3+ years of industry-related experience in drug development and/or commercialization
- 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

**Additional Skills/Preferences:**

- Knowledge of FDA procedures and practices (CFR guidelines, Guidances, etc.)
- Demonstrated ability to influence without authority and ability to deliver complex projects against a timeline.
- Strong communication skills (active listening, verbal, and written)
- Demonstrated ability to apply systematic thinking/mindset to business problems and opportunities
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
- Recent experience reviewing advertising and promotional materials for prescription drug products.
- Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.)

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

$132,000 - $193,600

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/Fellow, Research, Oligonucleotide Chemistry

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.

We serve an extraordinary purpose. For more than 140 years, we have worked diligently to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

The successful candidate will have a strong research track record in oligonucleotide chemistry, with demonstrated experience in advancing candidates to clinical evaluation. Additionally, they should exhibit strong analytical skills, maintain a systematic approach, and consistently apply data-driven decision-making practices. The scientist will collaborate with multidisciplinary teams across key Lilly therapeutic areas (e.g. Neuroscience, Pain/Neuronal Health, Diabetes and Complications, Immunology) to perform experiments to aid development of oligonucleotide drug candidates for the next generation of RNA therapies. They will also have a demonstrated track record of prioritizing people development through inclusive leadership, mentorship, and a commitment to fostering individual growth and team excellence.

**Key Responsibilities Include:**

- Hire, develop, and supervise a team of Ph.D.- and associate-level scientists to support a diverse portfolio of oligonucleotide medicines, partnering closely with therapeutic area thought leaders
- Lead the screening, design, and SAR optimization of innovative oligonucleotide constructs—including siRNA, ASOs, and conjugates—to advance differentiated clinical candidates.
- Lead the integration of AI/ML into oligonucleotide strategy
- Partner with legal to develop a comprehensive IP strategy for novel oligonucleotide medicines
- Clearly present and summarize results to team members and internal teams
- Develop the vision and drive the advancement of technical capabilities for transformative enterprise impact
- Demonstrate learning agility by quickly absorbing new scientific concepts, embracing new technologies, and applying insights across diverse oligonucleotide discovery challenges.
- Leverage exceptional communication (oral, written), organizational, collaboration, EQ, and leadership skills.
- Keep safety as a top priority at all times, striving toward an interdependent safety culture.

**Basic Qualifications:**

- Ph.D. in chemistry, or related field, with \>10 years of industry experience in oligonucleotide discovery and development

**Additional Skills/Preferences:**

- The ideal candidate will be a recognized leader in the field of oligonucleotide therapeutics with an established network and track record of delivering drugs to the clinic.
- Experience with extra-hepatic delivery of oligonucleotides and conjugates
- Demonstrated skills for data-driven study design, timeline and partner management, competitive intelligence, and resource planning
- Clear and defined management style
- Excellent communication, interpersonal skills, and team-player mentality
- Demonstrated initiative and appropriate risk-taking
- High level of organization and attention to detail

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

$240,000 - $385,000

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

Research Advisor, Drug Product - SMDD

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 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.

**Organization 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 35,000 employees 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 are looking for people who are determined to make life better!

**Position Brand Description:**

The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs is involved in key activities for the advancement of small molecules, peptides, and oligonucleotides from early discovery phases to commercialization. Our scientists and engineers develop innovative technical and business solutions across a portfolio of projects using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. Through recognizing the value of a hardworking, diverse, and inclusive workforce, SMDD delivers on these responsibilities and helps bring the next generation of life changing medicines to patients. Our team is looking for highly motivated and creative candidates who will work on the integration of early drug discovery, preclinical, and clinical activities with a focus on drug product design and development.

**Responsibilities:**

Candidates must possess a strong background in fundamental pharmaceutical sciences including formulation development, biopharmaceutics, solid state and be able to integrate this understanding with knowledge of disease state, therapeutic area, and patient preferences to develop drug products. Specific responsibilities for this role include:

- Apply drug delivery fundamentals towards designing and optimizing phase appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
- Predict and assess the in vivo performance of drug molecules and formulations in preclinical species and humans using molecular properties and preclinical data. Leverage modeling to guide the development of preclinical and clinical formulations to enable the delivery of a broad range of synthetic molecules.
- Refine clinical drug product prototypes, identify and mitigate technical risks to enable commercial products.
- Collaborate and communicate project specific challenges and opportunities with key partners to plan and manage short/long term development activities aligned with the global CMC strategy.
- Engage and influence internal and external scientific communities. Develop collaborations to solve technical challenges, identify and implement novel drug delivery and manufacturing technologies, influence clinical study design to benefit our patients.
- Author and review high quality technical reports, peer reviewed publications, and regulatory documentation to support new technologies and/or regulatory submissions.

**Basic Requirements:**

- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or other related fields with 0-5 years of demonstrated experience in pharamaceutical product development.

**Additional Skills/Preferences:**

- General understanding of solid-state forms, screening, and instrumentation used in characterizing physical properties of pharmaceutical solids. Experience in developing the relationship of these properties to product quality, performance attributes, and process development.
- Experience in technical considerations for equipment design and integration, process monitoring, integration of process analytical technology (PAT) systems, and scientific approaches on control strategies. Involvement with modeling and simulation tools, data analytics and predictive analytics.
- Experience in design, development, control, and optimization of drug product manufacturing unit operations, especially knowledge in continuous manufacturing within the pharmaceutical industry.
- Experience supervising or guiding the work of other scientists.
- Basic understanding of regulatory/GMP aspects pertaining to development and clinical testing of drug products.

**Additional Information:**

- Possible exposure to chemicals, allergens, and loud noises.
- Travel: 0 to 10%
- Position Local: Onsite Monday through Friday, Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$126,000 - $204,600

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

Senior Research Advisor / Research Advisor, Analytical Chemistry – TIDES, SMDD

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 Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.

The Senior Research Advisor / Research Advisor, Analytical Chemistry – TIDES, will serve as the analytical lead for early-phase synthetic peptide and oligonucleotide (TIDES) programs, from pre-clinical enabling studies through first-in-human clinical supply. This is an externally focused role: the successful candidate will provide the analytical leadership that enables GLP and GMP campaigns executed at contract manufacturing and testing organizations, and will translate that work into the control strategies and IND documentation that support Phase 1 entry. Working within a multidisciplinary team of chemists, formulation scientists, and engineers, and partnering closely with Quality and Regulatory CMC, this individual will own the analytical package for their molecules while accessing world-class internal capabilities for peptide and oligonucleotide characterization.

**Responsibilities:**

- Serve as the analytical lead for early-phase TIDES molecules, owning the phase-appropriate control strategy for drug substance and drug product.
- Provide technical direction and oversight to CMO and CRO partners: define analytical deliverables, approve method development and qualification protocols and reports, oversee method transfer and verification, assess external data packages, and drive resolution of OOS/OOT results and analytical investigations.
- Oversee the analytical elements of GLP and GMP campaigns, including readiness assessment, release and in-process testing, reference standard qualification, batch data review, and support of drug substance and drug product disposition with Quality.
- Author and review CMC sections of INDs and CTAs — analytical procedures, validation summaries, specification justification, batch analyses, impurity and stability sections — and support responses to health authority questions.
- Establish and justify phase-appropriate specifications and stability programs, addressing related substances and process-related impurities, residual solvents and reagents (ICH Q3C, M7), elemental impurities, water and counterion, potency, and microbiological quality and endotoxin.
- Collaborate with chemists, formulation scientists, engineers, Quality, and Regulatory CMC to integrate analytical strategy with program plans, managing multiple concurrent molecules.

**Basic Requirements:**

- Ph.D. in analytical chemistry or bioanalytical chemistry, or a closely related scientific discipline with 2+ years of relevant industry experience; or M.S. with 5+ years; or B.S. with 7+ years of pharmaceutical or biotechnology industry experience in analytical development.
- Demonstrated experience in analytical method development, qualification or validation, and transfer for peptides, oligonucleotides, or small molecules.
- Deep working knowledge of chromatographic separations (e.g., reversed-phase, size exclusion, ion exchange) and mass spectrometry, with a general understanding of other techniques used for synthetic molecules (e.g., UV, GC, KF, ICP, NMR).
- Understanding of method performance attributes (e.g., specificity, linearity, precision, accuracy, LOD/LOQ) and the ability to set fit-for-purpose expectations for early-phase work.
- Experience in a GMP environment and familiarity with applicable ICH and compendial (USP/Ph. Eur.) requirements.
- Strong written and verbal communication skills, including technical documentation for cross-functional and external audiences.

**Additional Preferences:**

- Direct experience with solid-phase peptide synthesis (SPPS) and/or oligonucleotide synthesis and the characterization of the associated process-related impurities.
- Experience authoring or contributing to regulatory CMC documentation (e.g., IND/CTA, NDA/MAA) for peptides or oligonucleotides.
- Demonstrated experience overseeing CMO/CRO analytical activities, including campaign support and technical governance of external testing.
- Familiarity with GLP expectations for test article characterization and with first-in-human parenteral drug product testing.
- Demonstrated scientific leadership, the ability to influence without direct authority, and comfort prioritizing across programs in ambiguity.

**Additional Information:**

- Level: This position is posted at the Senior Research Advisor level; depending on the qualifications and experience of the selected candidate, it may be filled at the Research Advisor or Senior Principal Scientist level.
- Travel: 0 to 10%.
- Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N).

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

$126,000 - $204,600

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 VP-Assistant General Patent Counsel IP Procurement – Key Assets:

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.

Role Overview

Lilly is seeking an experienced and strategic patent attorney focused on providing solution-oriented advice and counselling for IP issues facing Lilly in development, commercialization, and discovery of pharmaceutical products. This position requires close collaboration with other members of the Lilly Legal Patent team, project teams and business leadership. Individual must be energized by working in a dynamic environment with substantial responsibility for key assets. This position reports to the Associate Vice President – IP Procurement and Strategy.

Responsibilities

- Develop comprehensive global patent strategies for key pharmaceutical assets, including developing patent application filing strategies covering innovations from discovery, clinical development, manufacturing and beyond, drafting and prosecuting patent applications in all jurisdictions, and assessing freedom to operate.
- Proactively analyze IP risks and develop sound strategic and tactical approaches/solutions with appropriate consideration of business objectives and competitive environment.
- Advise teams and senior management about exclusivity, patentability, freedom to operate, and risks in a manner consistent with the law, ethics, and Lilly policies; communicate advice in a clear and concise manner.
- Lead with a continuous improvement mindset by remaining well versed in global laws, court precedents, and regulations pertinent to pharmaceutical products; apply knowledge appropriately in carrying out individual responsibilities as well as identifying opportunities within the team and organization.
- Prioritize, lead, and manage projects; contribute to the implementation of new policies and procedures; lead task-directed teams.
- Contribute to efficiency, collegiality, and collaboration.

Basic Qualifications:

- Doctor of Jurisprudence (J.D.) degree from an accredited U.S. institution.
- At least ten years of post-JD experience as a practicing patent attorney in a law firm or industry, with significant experience developing comprehensive patent strategies for pharmaceutical assets and significant patent prosecution experience. Experience with patent enforcement a plus.
- Presently admitted to practice law in at least one US jurisdiction and presently licensed to represent clients in patent matters before the USPTO; in good standing in each state and in the USPTO; no discipline issues on record.
- Bachelor’s degree or higher in a scientific field that, together with prior work experience, provides essential background for effective communication with scientists and management about the scientific aspects of discovery, development, manufacturing, and commercialization of pharmaceutical products, including small molecules, peptides, antibodies, conjugates, and genetic medicines.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences:

- Highly motivated and collaborative partner with the ability to work effectively with team members and members of management across all levels of the organization.
- Demonstrated leadership and effectiveness in working with senior leadership. Ability to establish strong relationships with business partners and with research and development teams to further IP strategy aligned with business objectives.
- Experience in the pharmaceutical industry in a scientific position in drug discovery or development, or demonstrated significant experience with and knowledge of drug discovery and development, and/or with patent litigation relating to pharmaceutical products.
- High learning agility; creative problem solver; ability to deal with complexity and make the complex understandable; high curiosity; continuous improvement of self and Lilly; accepting and leading change; agility to adapt and evolve.
- Ability to influence and lead boldly in a dynamic environment.
- Exceptional patent law acumen.
- Ability to organize, effectively work on and prioritize multiple complex projects simultaneously to meet project deadlines on time.

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

$229,500 - $371,800

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

Novo Nordisk

IT Validation & Compliance Lead (Onsite)

**About the Department**

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

**The Position**

The purpose of Lead IT Validation & Compliance position is to provide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site. This position ensures that IT solutions are implemented and released to use in compliance with relevant regulations and standards facilitating the seamless transition and handover of projects to service operations with key stakeholders. It plays a critical role in ensuring governance and continuous improvement as an enabler supporting product quality, patient safety, and data integrity, and contributes to the organization's goals of improving the lives of people with chronic diseases. This is an onsite based position at our GMP bioproduction facility in West Lebanon, NH.

**Relationships**

Reports to: Sr. Manager, IT Operations

**Essential Functions**

- Computer Systems Validation Expert
  - Involved in all IT solutions validation activities what includes but is not limited to: IT Infrastructure, IT Systems, and Computerized Equipment’s supporting Laboratories, Manufacturing, and Business Areas like Facilities and Warehousing
  - Ensure that IT solutions are compliant with relevant regulations and standards, e.g. 21 CFR Parts 11, EU Annex 11, and GAMP requirements among others
  - Facilitate, review, approve and as required develop validation deliverables what includes but is not limited to URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ), Operating and Maintenance Instruction
  - Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies
  - Provide guidance and support to project teams on validation and qualification requirements
  - Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards. Work to identify efficiencies in the CSV program approach. Work to apply lessons learned, and stay informed of industry regulatory changes as it applies to CSV
  - Perform assigned Quality Systems activities including Document Management system, Change Control, Deviations, and CAPA’s
  - Writing and/or revising procedures applicable to CSV activities
  - Work in collaboration with the Engineering group to prepare the validation, requalification, and maintenance program
- CSV Service Delivery Management
  - Facilitate the seamless transition and handover of projects to service operations with key stakeholders
  - Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements
  - Participate as an CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use
  - Collaborate with cross-functional teams to ensure that all IT solutions are properly documented and released to use
  - Ensure that all documentation and processes are following regulatory requirements and Novo Nordisk standards
- Leadership and Collaboration
  - Provide leadership and expertise in IT CSV, process improvement, and project coordination
  - Collaborate with cross-functional teams to ensure that IT solutions meet business needs and are delivered on time and within budget
  - Coach and mentor personnel, and provide guidance as needed
  - Participate in process group meetings and contribute to process group activities
    - Ensure that all activities are aligned with Novo Nordisk Way Essentials and support the organization's mission to improve the lives of people with chronic diseases
  - The role will spend the majority of its time on project activities and process improvement within these areas of accountability (key essential functions above), incorporating cLEAN tools for visual management to track service delivery performance and communicate progress to stakeholders; Problem solving, handling deviations ensuring that deviations are properly documented, investigated, and resolved in a timely manner, and planning ensuring that changes are properly documented, assessed for impact, and implemented in a controlled manner. It also develop and deliver training programs for CSV and process improvement initiatives
  - Responsible for communicating effectively with stakeholders at various levels of the organization to ensure that CSV issues, improvement opportunities, and service delivery meet business needs and are aligned with regulatory requirements and Novo Nordisk standards. Moreover, will also perform other duties as assigned

- Other duties as assigned
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

**Qualifications**

- Education and Certifications:
  - Bachelor's degree in Information Technology or related field of study from accredited college or university with a minimum of seven (7) years of experience in IT compliance, preferably within the pharmaceutical industry API and/or Finish Production Manufacturing, required
  - Master’s degree in Information Technology or related field of study from accredited college or university preferred with a minimum of five (5) years of experience in IT compliance, preferably within the pharmaceutical industry API and/or Finished Production Manufacturing, required
  - Minimum of five (5) years of experience in Validation & Testing of IT solutions, required
  - COBIT Certification is preferred
  - Lean Six Sigma Green Belt or Black Belt is preferred
  - Experience with electronic application lifecycle software, from requirements gathering to testing and deployment, preferrable HP ALM, required
  - Experience as SME participating in Audits and Inspections, required
  - Experience on GxP, change management and deviation handling, required
  - Experience with Incident, Problem, and Change Management in IT, required
  - Excellent writing and communication skills, in English, required
  - Excellent customer service skills and ability to collaborate effectively in a team environment, required
  - Excellent problem solving, negotiation, conflict management, and interpersonal skills, required
  - Excellent planning, organizing, decision making and deal with complexity and ambiguity, required
  - Strong computer skills and MS Office Expert, required

**Physical Requirements**

0-10% overnight travel required. This position may lift up to 33lbs/15kg occasionally, and/or up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetition including substantial movement of wrists, hands, and or fingers. The ability to speak, listen, and understand verbal and written communication. The ability to stoop, kneel, crouch, reach, stand, and walk. The ability to push, pull, lift, finger, and grasp. Visual acuity to perform close activities such as: reading, writing, and analyzing; operating a motor vehicle or heavy equipment, and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including noise, inside and outside conditions including temperature changes; atmospheric conditions including odors, fumes, and dust.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

New Hampshire

Counsel, Commercial

**About the Department**

The Legal department is comprised of our Legal and Patents functions. We depend on our legal team to help drive growth and maintain the highest level of standards and practices across all of our legal efforts. It’s a tall order, which is why we only hire those who thrive on protecting the interests of our patients, employees and business, all while creating and implementing efficient and innovative solutions. As part of the team, you’ll work with employees across the organization to oversee legal matters and provide guidance on strategies that drive business and policy priorities and shape the reputation of Novo Nordisk Inc. (NNI). At Novo Nordisk, your skills, dedication and ambition will help us change lives for the better. In exchange, we’ll offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Are you ready to realize your potential?

**The Position**

Provide legal counsel to global healthcare company on relevant issues involving application of U.S. law, regulations and industry standards.

**Relationships**

Acts as Counsel on the Clinical Commercial and Corporate Law team. Interacts with department colleagues and individuals in other NNI departments, including but not limited to Medical, Regulatory, Marketing, Sales, Commercial Operations and Ethics, Compliance & Privacy. May interact with government agencies, law firms, trade organizations and other external agencies. Reports to a Managing Assistant General Counsel.

**Essential Functions**

- In collaboration with other attorneys, serves as a legal advisor for assigned functions to help appropriately shape and execute strategy, objectives and initiatives
- Work with other attorneys and stakeholders to advise on cross-functional initiatives including promotional and other material review committees
- Additional areas of responsibilities may include, but are not limited to:
  - Flexibly supporting different teams, brands and functional areas in response to evolving business needs
  - Providing timely, practical and compliant solutions for a wide range of commercial legal issues while effectively managing risks
  - Identifying new laws, regulations and industry trends affecting the company and assist with development of policies and training as needed
  - Advising on interactions with health care providers, patients and payors in compliance with fraud and abuse laws such as the U.S. Anti-Kickback Statute and industry codes, such as the PhRMA Code on Interactions with Healthcare Providers
  - Participating in product lifecycle planning
  - Drafting, reviewing and negotiating contracts
  - Performing other duties as assigned

**Physical Requirements**

0-10% overnight travel required.

**Qualifications**

- A J.D. is required. NJ bar admission or ability to obtain limited in-house counsel license required
- 4+ years of legal experience preferred, some of which must have been spent working in at least one of the following: (1) at the FDA; (2) supporting the pharmaceutical sector; or (3) product liability litigation
- Candidates with prior experience with pharmaceutical product liability defense or enforcement litigation are preferred
- Additional experience within the healthcare/pharmaceutical industry (including experience with FDA, advertising and promotion, anti-kickback, antitrust, privacy) preferred though not required
- Strong problem-solving skills - demonstrates and exercises creativity and initiative
- Strong written and verbal communications skills - able to effectively collaborate and communicate with other client groups within the company

The base compensation range for this position is $120,300 to $222,600. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

New Jersey

AbbVie

Corporate Counsel-Patent

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

AbbVie is searching for an in-house Counsel for our Patent Prosecution group, part of AbbVie’s Intellectual Property, Transactions, and Innovation legal team. This position will support AbbVie’s pharmaceutical products and be based in our offices in North Chicago, IL, Waltham, MA, South San Francisco, CA, or Irvine, CA with a hybrid work model (on site 3+ days/week).

Acting individually and in cross-functional teams, the Counsel will develop and implement intellectual property strategies for AbbVie’s products and product candidates.

**Responsibilities:**

- Maximize AbbVie’s competitive position through creation and implementation of intellectual property strategies
- Provide legal advice and counsel to cross-functional R&D and business teams on a variety of IP-related matters
- Draft, file, and prosecute strategically useful patent applications worldwide both directly and through management of outside counsel
- Challenge and defend patents in IPR, opposition, interference, and other post-grant proceedings
- Conduct prior art searches, analyze third-party patent positions, and conduct due diligence to support business development activities

Qualifications

- JD degree from an accredited law school, state bar admission enabling in-house practice (specific state not required), and registration to practice before the USPTO
- 2+ years of experience practicing patent law as an attorney or patent agent at a law firm and/or life sciences company, including substantial U.S. and foreign patent prosecution
  - Experience with India, China, and emerging markets a plus
- Technical background relevant for pharmaceutical patent prosecution, such as:
  - Experience with small molecule and/or biological pharmaceutical discovery & development, and/or
  - Technical degree in relevant field, such as molecular biology, biotechnology, biochemistry, biology, chemistry, chemical engineering, or biomedical engineering
- Strong legal, analytical, communication, collaboration, and people skills
- Demonstrated ability to manage complex projects to meet deadlines

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>)

Illinois

Senior Counsel, Transactions,

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 Senior Counsel, Transactions, will be responsible for identifying and resolving highly complex legal issues and drafting and negotiating highly complex corporate transactions. The attorney should:

- Have extensive experience with managing **M&A and pharmaceutical licensing and collaboration/joint venture transactions**.
- Keep abreast of changes in laws that affect pharmaceutical licensing, and M&A transactions, including antitrust/competition, and other corporate and IP matters.
- Be capable of regularly negotiating highly individualized and sophisticated agreements independently with third parties on matters of strategic importance that affect a substantial portion of AbbVie’s business or are areas of significant importance to management.
- Be capable of regularly engaging in due diligence and independently interpreting complex existing agreements and advising on complex situations that may arise related to transactions.
- Select and direct the work of outside counsel, including defining project objectives and managing projects.
- Maintain and ensure compliance with applicable corporate and divisional policies and procedures.

**Additional Responsibilities:**

- Analyze and clearly communicate legal advice designed to maximize outcomes for patients and for AbbVie on complex, strategic agreements related to pharmaceutical licenses and collaborations and other strategic alliances.
- Assess and counsel on antitrust and competition risks and considerations, and competition filings, with respect to transactions in multiple jurisdictions.
- Provide clear advice to clients, including management, ensuring that advice maximizes the potential of our pipeline.
- Use good judgment in determining whether and when to elevate issues to senior attorneys and senior management.
- Assist senior legal staff on matters of significant importance to AbbVie that affect a substantial portion of AbbVie's business.
- Serve as recognized source, for both management and other attorneys, of innovative ideas in complex areas of law, business, or technology.
- Provide legal guidance, supervision, and support to paralegals and legal support staff

Qualifications

- Required:
  Juris Doctor (J.D.) from an accredited law school
  Active license to practice law in job location
  Minimum of 4 years of legal experience, in-house or healthcare compliance experience preferred
- Preferred:
  Exposure to biopharma, healthcare, or life sciences compliance topics
  Demonstrate ability to advise business clients and assess legal risk in real time
  Experience handling complex matters with a degree of autonomy and cross-functional collaboration
  Strong written and verbal communication skills, with the ability to translate legal complexity into business clarity

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 thisposting 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 anduntil 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>)

Associate General Counsel, Patent Prosecution - India

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

AbbVie is searching for an in-house Associate General Counsel for our Patent Prosecution group, part of AbbVie’s Intellectual Property, Transactions, and Innovation legal team. This position will support AbbVie’s pharmaceutical products and be based in our offices in North Chicago, IL, Waltham, MA, South San Francisco, CA, or Irvine, CA .

Acting individually and in cross-functional teams, the Associate General Counsel will develop and implement intellectual property strategies for AbbVie’s products and product candidates, with a particular emphasis on protecting the Indian market.

**Responsibilities:**

- P**rovide legal advice and counsel to cross-functional R&D and business teams on a variety of IP-related matters and serve as a subject matter expert on patent strategy in India**
- Maximize AbbVie’s competitive position through creation and implementation of intellectual property strategies
- Draft, file, and prosecute strategically useful patent applications worldwide both directly and through management of outside counsel
- Challenge and defend patents in IPR, opposition, interference, and other post-grant proceedings, including implementing strategies to expedite resolution of Indian proceedings
- Conduct prior art searches, analyze third-party patent positions, and conduct due diligence to support business development activities

Qualifications

- JD degree from an accredited law school, state bar admission enabling in-house practice (specific state not required), and registration to practice before the USPTO
- **8+ years of experience practicing patent law as an attorney or patent agent at a law firm and/or life sciences company, including substantial experience obtaining and defending Indian patents**
- Technical background relevant for pharmaceutical patent prosecution, such as:
  - Experience with small molecule and/or biological pharmaceutical discovery & development, and/or
  - Technical degree in relevant field, such as molecular biology, biotechnology, biochemistry, biology, chemistry, chemical engineering, or biomedical engineering
- Strong legal, analytical, communication, collaboration, and people skills
- Demonstrated ability to manage complex projects to meet deadlines

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 thisposting 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 anduntil 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>)

Director, Organizational Research

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**

As the Director, Organizational Research, you will lead an enterprise consulting practice, developing the vision, strategy, and execution plan for an organizational capability, responsible for delivering clear value to AbbVie. These capabilities are critical to increase readiness and performance in our quickly evolving business.

You will lead a team of Associate Director-level, and Manager-level consultants and practitioners (direct reports) to deliver on the strategy through enterprise- and function-level client engagements and solutions. Clients for this work are L2-L4 executive leaders, if not the enterprise (L1), and projects are multi-stage in nature, spanning up to one year. They require expertise and delivery not just in the Practice Director’s capability area of focus but across capabilities – delivering a holistic, multi-faceted solution set. You will leverage disparate data sets and external research, as well as deep organizational business knowledge and political savvy on how to create exceptional outcomes for the enterprise.

**Core Responsibilities**

- Leads enterprise capability area for Organizational Research to drive organizational effectiveness work that directly aligns with and supports the strategic roadmap, critical capabilities, culture, engagement and executive-level leader performance
- Sets a vision, strategy, and execution plan for delivering the capability, including its continual increase in value to performance of the organization
- Analyzes multiple internal and external data sources to identify novel insights and trends, as inputs to the capability’s strategy and execution details
- This leader will represent AbbVie externally as well – participating in member consortium groups, speaking at conferences, coordinating industry benchmarking, and managing academic partnerships focused on employee research.
- Consults with executive business and HR leaders across AbbVie for business development of client-facing engagements, as well as to identify opportunities to improve organizational culture, engagement performance across enterprise, team and leader levels
- Manages a team of consultants on the execution of the strategy, including multi-consultant project teams that may include consultants from other Practices (cross-practice team leadership)
- Directly responsible for owning the client relationship of L2-L4 leaders, scoping, contracting (including pricing of up to six-figure dollar engagements), stakeholder management, and project outcomes
- Leads delivery of critical project components: environment and stakeholder assessment, strategy, culture development, team alignment, and change readiness; regularly includes being accountable to recommend strategies that transform employee data into insightful summaries that address business problems.
- Influences and guides CHRO, executive leaders, cross-functional leadership teams, and HR partners on areas of focus, prioritizing needs, best-fit solutions, and next generation capabilities
- Identify and build additional growth mechanisms that enhance the Practice Capability at AbbVie
- Diagnoses root causes and recommends strategies that fit the culture and integrate across the organization
- Coaches executive leaders on organizational effectiveness topics, such as readiness for and leading through change, culture, organization design efforts, and team leadership

Competencies

- Strategy and strategic planning, with particular emphasis on strategic thinking while front of room or “on your feet”
- Establishing instant credibility in front of executive leaders and building executive leader relationships
- Ability to summarize complex research into easy-to-understand insights while influencing stakeholders to maximize impact of research findings.
- Leads without authority
- Influences across all levels and geographies
- Data analysis and insights generation
- Effectively navigates the organization and is able to swiftly adjust to new information
- Business relationship management
- Superb communicator
- Resource planning
- Business acumen
- Innovates in the face of new challenges
- People leadership, development and coaching skills
- Political savvy
- Action-orientation over theoretical reliance
- Prioritization

Qualifications

**Education and Experience**

- Bachelor’s Degree required; or master’s degree quantitative fields such as Statistics, Engineering, Operations Research, Computer Science or Economics. PhD preferred.

- 12 years+ related background/experience, including:
  - Management consulting or leading consultative work
  - Published research, academic partnerships.
  - Employee Surveys and people analytics
  - Assessments; IO Psychology
  - Influencing and collaborating globally and with executive leaders
  - Strategy setting and accountability for a strategic plan
  - People leadership
  - Organizational model principles and application
  - Team effectiveness principles, design, and facilitation
- A proven, strong performer with leadership experience in multiple aspects of the business
- Record of driving business performance in times of change
- Knows what it takes to develop strong organizational cultures, drive employee engagement, develop leaders and create high performing teams.

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>)

Principal Peptide Process Engineer, Research 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.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:**

Process Engineers in Product Development Science & Technology support API projects through all the phases of late stage development, commercialization, product life cycle. This position will be responsible to ensure processes can be run safely, addressing scale-up issues and developing and implementing robust API process steps from the lab to a manufacturing environment. Once commercialized, the Process Engineer is responsible for continuous improvement activities, technical transfer to manufacturing sites, and resolution of technical manufacturing issues in a commercial setting. Effective cross functional interactions with quality and regulatory functions and on-site manufacturing personnel is key for successful job performance.

The Peptide Process Engineer will research and/or conduct project activities with a group of scientists within the individual’s area of expertise by effectively mentoring, guiding, and/or supervising scientific personnel. Independently conceive, execute, and communicate novel multi-disciplinary research or development strategies that achieve project and area goals. This role will oversee the design, implementation, and optimization of peptide synthesis manufacturing processes from development to commercialization.

**Major Responsibilities:**

- Develops and achieves discipline strategy in alignment with functional goals and key scientific objectives.
- Conceptualizes and implements approaches using combinations of engineering principles.
- Utilizes knowledge of engineering, literature, and experience to guide decision for complex situations.
- Collaborates with experts within function to integrate scientific objectives into activities associated with development of new/improved products or technology.
- Advances scientific expertise within function. Proactively advises and shares knowledge and expert opinions with subordinates, peers, and senior management. Mentors and trains functional colleagues and assesses current and emerging business challenges enabling functional goal achievement.
- Ensures quality and effectiveness of key results of major project plans within function through sound design, early risk assessments, and implementation of fallback strategies.
- Sources and identifies emerging scientific trends from multiple internal and external sources and assess relevance. Integrates trends into functional short-term objectives. Advances technology and direction within area of discipline.

**Level of Leadership Activities:**

- Leads resolution of compliance quality issues and documents drafting.
- Presents results of projects both internally and externally.
- Reviews and critiques presentations for others.
- Establishes project operation criteria and technical standards for excellence. Generates new product ideas.
- Prepares and aligns impact goals with department divisional goals.
- Actively participates in cross-functional technology transfer teams including team members from development and manufacturing.

Qualifications

- Bachelor’s Degree in Chemical Engineering or related field with 16 years of related work; Master’s Degree in Chemical Engineering or related field with 14 years of related work; PhD in Chemical Engineering or related field with 8 years of related work experience.
- Proven ability to innovate with a history of new or improved product releases.
- Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.
- Possess thorough theoretical and practical understanding of own scientific discipline.
- Conceives, designs, conducts research and development for major process to be commercialized.
- Leads the development of processes and programs to optimize or achieve the plant efficiency, product quality, cost control, customer specification or product design changes.
- Leads the technical investigative troubleshooting of product failures and recommends remediation direction.
- Primary author of publications, presentations, regulatory documents, and/or primary inventor of patents.
- Experience and/or education with API and/or natural product processes in pharmaceuticals.
- Peptide development and/or manufacturing experience.
- Interacts and leads cross functional teams and shares information. Has demonstrated technical leadership in a multi-disciplinary environment.
- Strong verbal, written and presentation skills.

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 thisposting 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 anduntil 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>)

Associate General Counsel-IP Due Diligence

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

AbbVie is searching for an in-house Associate General Counsel for our IP Due Diligence group, part of AbbVie’s Intellectual Property, Transactions, and Innovation legal team. This position will support AbbVie's business development activities, including mergers and acquisitions, licensing deals, option agreements, and venture transactions, and will be based in our offices in North Chicago, IL, Waltham, MA, South San Francisco, CA, or Irvine, CA with a hybrid work model (on site 3+ days/week).

Acting individually and in cross-functional teams, the Associate General Counsel will lead and execute IP due diligence for business development transactions, assess intellectual property risk and opportunity across AbbVie's pipeline and target portfolios, and provide strategic IP counsel in support of AbbVie's M&A, licensing, option, and venture activities.

**Responsibilities:**

- Lead and execute comprehensive IP due diligence for M&A, licensing, option, and venture transactions, assessing patent coverage, freedom-to-operate, validity, enforceability, and competitive landscape
- Provide legal advice and counsel to cross-functional business development, R&D, and commercial teams on IP matters arising in the context of transactions and strategic partnerships
- Analyze and assess third-party patent portfolios and competitive landscapes, including claim scope, prosecution history, litigation exposure, and conduct patent landscaping across counterparty portfolios or various mechanisms-of-action to identify strategic risks, white-space opportunities, and competitive intelligence insights in support of transaction structuring and risk mitigation
- Prepare and present clear, actionable due diligence reports and risk assessments to senior legal, business, and scientific stakeholders
- Partner with external counsel and internal scientific teams to conduct prior art searches, validity assessments, and freedom-to-operate analyses in support of transaction due diligence
- Lead and support negotiations in connection with licensing, M&A, option, and venture transactions, working closely with business development and legal colleagues
- Build and manage productive relationships with science, evaluation, and business development teams to ensure IP considerations are integrated throughout the deal lifecycle
- Interact regularly with IP team leadership to provide updates on transaction diligence activities, escalate key risks, and align on IP strategy
- Participate in technology assessment and cross-functional teams supporting R&D external opportunity diligence, evaluating the IP implications of in-licensing, co-development, and acquisition targets
- Support and, where appropriate, manage patent prosecution activities across a range of modalities, including complex and simple biologics, peptides, small molecule pharmaceuticals, or device-related inventions, coordinating with outside counsel and internal R&D teams to develop and execute prosecution strategies aligned with business objectives

Qualifications

- JD degree from an accredited law school, active state bar admission enabling in-house practice (specific state not required), and registration to practice before the USPTO as a patent attorney
- ~8 years of experience practicing patent law as a patent attorney at a law firm and/or life sciences company, with substantial experience conducting IP due diligence in a pharmaceutical or biotechnology context
  - Prior due diligence experience in simple biologics, complex biologics, peptides, and other small molecule pharmaceuticals
  - Experience with biosimilars or generics portfolios
- Technical background relevant for pharmaceutical IP due diligence, such as:
  - Experience with small molecule and/or biological pharmaceutical discovery & development, and/or
  - Technical degree in a relevant field, such as molecular biology, biotechnology, biochemistry, biology, chemistry, chemical engineering, or biomedical engineering
- Strong legal, analytical, communication, collaboration, and people skills
- Demonstrated ability to manage complex projects to meet deadlines

**Preferred Qualifications:**

- Prior pharma or biotech due diligence experience in M&A, licensing, or option deal transactions
- Experience with biosimilars or generic pharmaceutical patent portfolios
- Experience advising on venture transactions or strategic collaborations with IP components

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 thisposting 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 anduntil 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>)

Senior Counsel: Operations and Pharmacy Legal

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

Empower business innovation through strategic legal guidance. As a Senior Counsel at AbbVie, you will partner closely with cross-functional teams to shape decisions that bring great possibilities to patients ethically and effectively. This role builds on foundational experience, enabling you to navigate regulatory complexity, assess risk, and influence business outcomes, all while developing leadership capabilities for long-term career growth. **The role will support various Operations stakeholders, including AbbVie’s onsite Pharmacy and advise on pharmacy regulatory compliance, controlled substance management, pharmacy licensure matters, as well as commercial contracts requests**.

**Responsibilities:**

- Serve as a key legal advisor to cross-functional business teams, providing proactive counsel on commercial, regulatory, or operational issues Interpret and apply U.S. laws and global regulations relevant to the pharmaceutical or healthcare environment Review and advise on contracts, business activities, and strategic initiatives to ensure legal compliance and alignment with company objectives. Support the development and implementation of legal policies, compliance programs, and training effort.
- Collaborate with internal and external partners to manage risk, resolve disputes, and influence outcomes Provide clear, timely guidance on evolving legal questions in a business-first manner
- Translate complex legal/regulatory issues into practical business advice.
- Draft, review, negotiate, and manage a wide range of commercial contracts.
- Advise the onsite specialty pharmacy team on federal and state pharmacy laws, including **DEA and state Board of Pharmacy regulations** governing controlled substance procurement, storage, dispensing, and recordkeeping.
- Support specialty pharmacy licensure and permit applications, renewals, and compliance audits across applicable jurisdictions, coordinating with Regulatory Affairs and Quality Assurance as needed.
- Partner with the pharmacy team to develop and maintain standard operating procedures, policies, and training materials that reflect current legal and regulatory requirements.

Qualifications

**Required**:

- Juris Doctor (J.D.) from an accredited law school. Active license to practice law in job location.
- **Minimum of 5+ years** of relevant experience practicing in-house at a pharmaceutical company, practicing as a member of a nationally recognized law firm in a life sciences or healthcare practice, or practicing as an attorney for a government agency, or any combination of the above.
- Experience advising on pharmacy-related legal matters.

**Preferred**:

- Exposure to biopharma, healthcare, or life sciences compliance topics
- Demonstrate ability to advise business clients and assess legal risk in real time
- Experience handling complex matters with a degree of autonomy and cross-functional collaboration
- Strong written and verbal communication skills, with the ability to translate legal complexity into business clarity

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>)