Marketing

AbbVie

Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology - Hybrid

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 Manager Regulatory Affairs US Advertising and Promotion-Immunology** combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

**Responsibilities:**

- Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
- Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
- Summarizes findings, under supervision, in concise reports for distribution within AbbVie
- Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
- Development and guides implementation strategies for promotional activities
- Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
- Effectively presents pertinent information to appropriate cross-functional groups.
- Effectively delivers difficult messages to commercial organizations without damage to relationships
- Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
- This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

- Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
- Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
- Experience working in a complex and matrix environment and exhibits strong negotiation skills
- Strong communication skills, both oral and written
- Experience in management capacity preferred
- Experience in US Regulatory Affairs Advertising and Promotion

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>)

California

Senior Scientist II - Biologics Drug Product Development

Company Description

**About AbbVie**

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

Job Description

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s R&D, is a global organization that is responsible for **drug product formulation and process development, and definition of the product presentation for biologics (proteins, conjugates, peptides, neurotoxins etc.)**  and genetic medicine (AAV, LNPs, Cell Therapy).

AbbVie is seeking a highly motivated candidate for the position of Senior Scientist II, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in **biologics drug product formulation development, predictive stability, in-use, and quality risk management (QRM)** . This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery research, analytical research and development, bioprocess development, combination products development, product development science and technology, pilot plants and third-party manufacturers.

**Key Responsibilities:**

- Lead matrix drug product teams for one or more internal and external projects and represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
- Lead the design and execution of biologics drug product formulation development, characterization and robustness studies.
- Serve as subject matter expert in biologics predictive stability modeling, in-use and administration procedures, and QRM.
- Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
- Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.

Qualifications

- Bachelors, Masters, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 12+ (Bachelors), 10+ (Masters), or 4+ (PhD) years of relevant industry experience.
- Proven ability to solve critical scientific problems.
- Experience leading drug product development as the functional lead within cross-functional teams
- Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins) and/or genetic medicine (AAV, LNPs, cell therapy) formulation development, and QRM.
- Strong experience in predictive stability modeling (statistical, phenomenological and mechanistic, and/or AI/ML) for biologics.
- Strong experience in in-use compatibility and stability for biologics products.
- Strong experience in quality risk management.

**Preferred Qualifications:**

- Understanding of relevant cGMP and regulatory guidance.
- Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) development, characterization, scale-up and technology transfer.
- Experience in managing third party manufacturers of sterile parenteral products.
- Experience with quality risk management and drug product control strategies.

**Key Competencies:**

- Deep scientific knowledge and significant hands-on experience with predictive stability modeling, administration procedures and risk management.
- Effectively communicates to influence without authority, drives technical excellence, and inspires continuous improvement.
- Builds strong relationships with peers and cross-functional partners to enable higher performance.
- Connects ideas from disparate fields, integrates data and information quickly, and takes risks to achieve the highest performance.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.

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>)

Illinois

Senior Manager Regulatory Affairs US Advertising and Promotion

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 Manager Regulatory Affairs US Advertising and Promotion** combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

**Responsibilities:**

- Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
- Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
- Summarizes findings, under supervision, in concise reports for distribution within AbbVie
- Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
- Development and guides implementation strategies for promotional activities
- Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
- Effectively presents pertinent information to appropriate cross-functional groups.
- Effectively delivers difficult messages to commercial organizations without damage to relationships
- Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
- This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
- Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

- Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
- Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
- Experience working in a complex and matrix environment and exhibits strong negotiation skills
- Strong communication skills, both oral and written
- Experience in management capacity preferred
- Experience in US Regulatory Affairs Advertising and Promotion

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>)

Data Strategy Lead - Hybrid

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:

The Clinical Data Strategy and Operations (CDSO) Data Strategy Lead serves as the study start-up domain expert and key strategic partner to the clinical study team, owning all data-related study start-up deliverables from protocol development through system design and go-live. The role leads cross-functional collaboration to ensure data strategies, standards, and technologies are consistently embedded into clinical plans, while translating complex data and technology concepts into actionable decisions for the study team. Through strong project management, risk oversight, and continuous process optimization, the Data Strategy Lead is key to ensuring successful clinical trial technology delivery.

Responsibilities:

- Serves as the CDSO study start-up subject matter expert and single point of contact for assigned studies, owning all data-related start-up deliverables from protocol development through system go-live.

- Leads data management study start-up end-to-end, partnering both within CDSO and across the study team to enable on-time study start. Leverages operational analytics and project management tools to optimize execution, track progress, and escalate and resolve issues affecting timelines or quality.

- Ensures consistency in data strategy, standards, CRFs, and surveillance approaches across studies and therapeutic area(s). Translates complex data, technology, and standards concepts into clear, decision-ready guidance for study teams.

- Drives the pull-through of critical-to-quality factors and data criticality assessments, ensuring they are translated and implemented into downstream data systems.

- Ensures adherence to federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and functional quality standards; stays abreast of evolving guidance.

- Influences without direct authority, using data and evidence to drive aligned, mutually beneficial outcomes for AbbVie.

- Leads CDSO innovation and process improvement initiatives and participates in cross-functional initiatives.

- Responsible for coaching and mentoring team members.

This role is a hybrid role with 3 days a week onsite.

Qualifications

- Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired.
- Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
- In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred
- Demonstrated performance as a functional leader
- Demonstrated ability to influence others without direct authority
- Demonstrated ability to successfully coach / mentor in a matrix environment
- Demonstrated effective communication skills
- Demonstrated effective analytical 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 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>)

Sachkundige Person / Qualified Person für Klinische Prüfpräparate (Bulk Drug Product) (all

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

Herzlich willkommen bei Abbvie! Als Teil eines internationalen Unternehmens mit über 58.000 Mitarbeitern weltweit und rund 3.500 Mitarbeitern in Deutschland hast Du die Möglichkeit, eng mit uns zusammenzuarbeiten, um die gesundheitlichen Herausforderungen von morgen zu meistern. Du hast eine Leidenschaft für die Verbesserung der Gesundheitsversorgung auf der ganzen Welt? Du möchtest Dein Fachwissen einsetzen, um die Lebensqualität von Patienten zu verbessern? In einem herausfordernden Arbeitsumfeld, das Dir die Möglichkeit bietet, Deine eigenen Fähigkeiten zu erweitern und zu entwickeln? Dann bist Du bei uns richtig!

Gemeinsam großes bewegen – als **Sachkundige Person / Qualified Person für Klinische Prüfpräparate (Bulk Drug Product) (all genders)**

Gestalte als Qualified Person (QP) die Zukunft der klinischen Prüfpräparate aktiv mit und übernehme eine verantwortungsvolle Schlüsselrolle entlang der Herstellung, Prüfung und Freigabe von Bulkprodukten. In einem dynamischen und regulierten Umfeld sichere höchste Qualitäts- und Compliance-Standards, treibe die Weiterentwicklung unserer Prozesse voran und leisten mit deiner Expertise einen wesentlichen Beitrag zur erfolgreichen Entwicklung innovativer Arzneimittel.

Hauptaufgaben

- Ausübung der Funktion als Qualified Person (QP) / Sachkundige Person gemäß AMG § 14 , GMP-Leitfaden und CTR No 536/2014
- Verantwortung für die Chargenfreigabe (GMP-Confirmation) von Prüfpräparaten (Bulkprodukte)
- Sicherstellung der ordnungsgemäßen Herstellung, Prüfung, Freigabe, Lagerung und des Versands von Prüfpräparaten sowie importierten Produkten
- Sicherstellung der Einhaltung gesetzlicher Anforderungen, Übereinstimmung mit IND/IMPD Einreichungen und der Produktqualität/-sicherheit
- Untersuchung und Bewertung von Qualitätsereignissen einschließlich Ursachenanalyse, pharmazeutischer Beurteilung sowie Definition und Nachverfolgung von CAPA-Maßnahmen
- Bewertung von Änderungen an Herstellprozessen, Prüfmethoden und relevanten Qualitätsdokumenten
- Aktive Mitarbeit in interdisziplinären Produktentwicklungsteams, z. B. in CMC- und Supply-Chain-Teams
- Erstellung und Revision von SOPs sowie Unterstützung bei der Erstellung und Verhandlung von Quality Agreements (QAA/TQA)
- Mitwirkung bei Audits, Behörderninspektionen sowie Bewertung neuer regulatorischer Anforderungen und Due Diligence- und Inlicensing-Aktivitäten
- Aktive Weiterentwicklung des Qualitätssicherungssystems für Prüfpräparate sowie kontinuierliche Optimierung relevanter Prozesse
- Initiierung und Begleitung von Maßnahmen zur Prozessverbesserung und zur weiteren Stärkung von Effizienz und Compliance

Qualifications

**Erfahrungen, die Sie zu einem starken Kandidaten für diese Rolle machen:**

- Approbation zum Apotheker oder gleichwertige Ausbildung gemäß Anforderungen des § 15, AMG, Abs 1,2
- Mehrjährige Berufserfahrung als Qualified Person vorwiegend für chemisch und/oder biologisch definierte Produkte und Wirkstoffe, idealerweise für Prüfarzneimittel
- Kompetenz in der Qualitätsbeurteilung von Wirkstoffen, Sachkenntnis nach §15, AMG Abs. 3a Nr.6 erwünscht
- Kompetenz in der Qualitätsbeurteilung von ATMPs (Advanced Therapy Medicinal Products), Sachkenntnis nach §15, AMG Abs. 3a Nr. 1 sind von Vorteil
- Weiterbildung zum Fachapotheker erwünscht (vorzugsweise Pharmazeutische Analytik, Pharmazeutische Technologie oder Arzneimittelinformation)
- Sehr gute Kenntnisse der nationalen und internationalem rechtlichen Vorgaben, cGMP Anforderungen und Regularien
- Sehr gute Kenntnisse in der Entwicklung, Herstellung und Prüfung von Arzneimitteln
- Ausgeprägtes analytisches Denkvermögen mit systematischer Analyse komplexer Situationen zur Identifizierung von Problemen und effektiven Problemlösungsstrategien
- Sicheres Auftreten, Entscheidungskompetenz und professionelles Handeln auch in kritischen und komplexen Situationen
- Ausgeprägte Teamfähigkeit sowie sehr gute Zusammenarbeit in cross-funktionalen und globalen Strukturen
- Hervorragende Kommunikationsfähigkeit im globalen und interdisziplinären Umfeld
- Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
- Kenntnisse in Lean Six Sigma und Projektmanagement sind von Vorteil

**Wie wir gemeinsam Großes bewegen**

- mit einem diversen Arbeitsumfeld, wo Du etwas bewirken kannst
- mit einer offenen Unternehmenskultur
- mit einer attraktiven Vergütung
- mit einem intensiven Onboarding inkl. einem Mentor \*in
- mit flexiblen Arbeitsmodellen für eine gesunde Work-Life-Balance
- mit einem betrieblichen Gesundheitsmanagement mit umfassenden Gesundheits- und Bewegungsprogrammen
- mit betrieblichen Sozialleistungen
- mit vielfältigen Karrieremöglichkeiten in einer internationalen Organisation
- mit hochkarätigen, attraktiven Entwicklungsmöglichkeiten
- mit einem starken, internationalen Netzwerk

Wir wurden mehrfach und weltweit zum „Great Place to Work“ gewählt und sind stolz darauf, unseren Mitarbeitern\*innen die Flexibilität zu bieten, die eine gesunde Work-Life-Balance gewährleistet. Wir nehmen unseren Einfluss auf die Umwelt und die Gesellschaft ernst und konzentrieren und deshalb darauf, regelmäßig etwas zurückzugeben. Wir engagieren uns für Gerechtigkeit, Gleichheit, Vielfalt und Inklusion (EED&I) – das ist von grundlegender Bedeutung für uns. Dazu gehört die Wertschätzung unterschiedlicher Perspektiven, die Schaffung einer integrativen Kultur und der würdevolle und respektvolle Umgang mit allen Mitarbeitern\*innen.

Bei AbbVie zählt Dein individueller Beitrag – Hilf uns, gemeinsam Großes zu bewegen. Sei ein Teil von unserem Erfolg und wachse mit uns – und wachse über Dich hinaus! Klingt wie die perfekte Karrierechance für Dich? Dann freuen wir uns auf Deine Bewerbung. Alles, was Du benötigst, ist ein vollständiger Lebenslauf – alles Weitere besprechen wir dann persönlich mit Dir.

Hast Du noch Fragen? Schicke gerne eine E-Mail an TalentAcquisition.de@abbvie.com. Wir freuen uns auf Deine Kontaktaufnahme!

Additional Information

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

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

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

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

Other Non-US

Scientist II, Biologics Drug Product Development

Company Description

**About AbbVie**

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

Job Description

The Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, multispecitics, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept.

We have an exciting opportunity for a Scientist I/II to join our team at our Bay Area site in South San Francisco, CA. This role is an onsite role in a lab-based function and will focus on driving drug product development through formulation, process and in-use and will be the HPLC/UPLC technical lead and subject matter expert. This position is ideal for a scientist with experience in biologics formulation and characterization who is passionate about chromatography and eager to support the team as to ensure utility and maintenance of HPLC/UPLC instruments. To be successful, candidates must thrive in a highly collaborative laboratory environment with daily face-to-face interactions across multiple scientific disciplines.

**KEY RESPONSIBILITIES INCLUDE:**

**Formulation & Biologics Drug Product Development**

- Independently lead and execute drug product development studies to support clinical studies, including formulation screening, in-use studies, and manufacturing process support.

- Generate robust scientific data and documentation to support IND/NDA/BLA regulatory submissions, CTD module documentation, and technical reports.

- Collaborate with cross-functional partners including Analytical Development and Drug Substance team to advance pipeline programs.

- Develop scientific understanding of formulation attributes and product quality characteristics through hands-on laboratory experimentation and data interpretation.

- Contribute to continuous improvement of formulation strategies and drug product processes, applying scientific rigor and innovation.

**HPLC/UPLC Subject Matter Expertise**

- Serve as the primary technical resource and owner for HPLC/UPLC systems within the Drug Product Development group and implement a system to keep HPLC/UPLC instruments maintained, operational, and minimize downtime.

- Lead troubleshooting and root-cause investigations for chromatographic instrumentation, methods, and data acquisition systems to maximize instrument uptime and laboratory productivity.

- Coordinate instrument maintenance, qualification activities, and vendor support while ensuring compliance with laboratory procedures and quality requirements.

- Act as an Empower software superuser by supporting users, troubleshooting data acquisition and processing issues, and promoting efficient data management practices using AbbVie data strategy tools.

- Develop and deliver HPLC training curricula, maintain SOPs and training materials, and serve as a technical resource and scientific consultant on HPLC-related matters.

- May provide guidance for HPLC/UPLC method adjustments to enable accelerated characterization of new molecules.

**Scientific Contribution & Communication**

- Independently analyze, interpret, and document experimental data in electronic lab notebooks (ELN) with clarity and completeness.

- Present scientific findings to project teams, management, and cross-functional stakeholders with confidence and scientific rigor.

- Author technical reports, SOPs and development summaries and contribute to regulatory documents, scientific publications, and patent applications as needed.

- Stay current with emerging trends and innovations in formulation science, analytical chemistry, and HPLC/UPLC technology; proactively apply learnings to internal programs.

Qualifications

**Education**

- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related discipline with typically 4-5 years (Scientist I) or 7+ years (Scientist II) of relevant industry experience
- Master’s degree in a related discipline with typically 2 years (Scientist I) or 5+ years (Scientist II) of relevant industry experience

**Required Experience & Skills**

- Demonstrated hands-on experience in biologics drug product development, including formulation development, characterization, and stability assessment.
- Strong practical understanding of protein degradation pathways and analytical characterization approaches used to assess biologic product quality.
- Broad and deep hands-on expertise with HPLC/UPLC across multiple modalities (e.g. RP, SEC, IEC, HIC, etc.) with a proven track record as an SME, including method development and troubleshooting capabilities
- Hands-on experience with analytical techniques used for protein characterization and stability testing (e.g., SEC, RP-HPLC, CE-SDS, icIEF, HIAC, MFI, DLS, SoloVPE or equivalent).
- Experience with in-use stability and/or clinical compatibility studies for biologic drug products preferred.
- Proficiency in scientific data analysis and statistical tools, especially chromatography data systems (e.g. Empower).
- Strong oral and written communication skills, with experience authoring reports, standard operating procedures (SOPs), and regulatory documents.
- Ability to independently manage multiple projects with competing priorities.
- Preferred Experience
- Experience with DoE (Design of Experiments) for formulation and process optimization.
- Prior experience supporting IND, NDA, or BLA filings.
- Experience contributing to scientific publications or patent applications.
- Experience in automation and data digitalization.

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 short-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>)

Senior Electrical Engineer, Combination Product Development

Company Description

**About AbbVie**

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

Job Description

**Sr. Electrical Engineer, Combination Product Development, R&D**

We are seeking an experienced Sr. Electrical Engineer to support the development of innovative drug-device combination products within our Combination Product Development team in R&D. In this role, you will lead electrical system design efforts for clinical development of advanced drug delivery systems, including on-body injectors, subcutaneous ambulatory infusion pumps, and other electromechanical systems.

This role will contribute to the development of new device and platform technologies, maintaining technical rigor and ensuring compliance with regulatory standards. This role will work closely with engineering colleagues in R&D and cross-functional colleagues in a global organization as well as maintaining strong working relationships with external development partners throughout the product development process.

**Responsibilities**

**Design and Development Leadership:**

- Work closely with external development partners through design and development efforts associated with electronic components of drug delivery systems
- Execute feasibility and initial development activities including needs definition, requirements, assessment of design fundamentals, and technology landscaping
- Conduct system architecture evaluation, including assessment of system design, testing, and analysis of electrical components
- Perform electronics design assessments including circuit design, PCB assessment, circuit analysis, evaluation of design margins, and testing requirements definition

**Technical Analysis and Validation:**

- Support system integration activities, reliability assessments, verification testing, and design validation to ensure products are technically robust and meet reliably goals
- Provide engineering analysis and design history file documentation to support development activities, including Design Inputs, Design Outputs, Protocols, Task Analysis, and risk assessments
- Support the lab and design verification teams with test plans, test setups, methods, investigations, and engineering confidence tests

**Cross-Functional Collaboration:**

- Engage and collaborate with clinical, project development, regulatory, quality, and operations teams, as well as external engineering partners to ensure alignment throughout device development
- Work across engineering disciplines (mechanical, software, systems engineering) to drive consensus and support execution on technical solutions
- Partner with cross-functional stakeholders to ensure development deliverables and timelines meet regulatory standards and quality expectations

**Professional Development and Process Improvement:**

- Establish and maintain working knowledge of technology trends and assess their relevance to combination product development
- Partner with external vendors to understand and evaluate future technology roadmaps
- Participate in and drive department continuous improvement initiatives focused on maximizing process efficiencies and enhanced collaboration
- Use appropriate project management techniques and stage/gate processes to ensure successful completion of assigned projects

Qualifications

**Education and Experience:**

- BS in Electrical Engineering or equivalent discipline, with typically 10+ years of relevant industry experience; MS in Electrical Engineering with typically 8+ years of relevant experience;
- Demonstrated experience in medical devices or combination product development
- Prior experience with subcutaneous injection devices, electromechanical devices, or digital/connected health technologies is highly desirable

**Technical Skills and Knowledge:**

- Demonstrated expertise in electrical system design for drug delivery systems
- Advanced understanding of circuit design, PCB design, and embedded systems; experience having designed and developed electrical systems from concept through product launch is a plus
- Proficiency with design tools, simulation software, and analytical modeling techniques
- Solid knowledge of applicable global regulatory requirements and industry standards (e.g., 21 CFR 820.30, ISO 13485, MDR)
- Understanding of modern, lean product development methodologies and stage/gate processes
- Experience with design verification and validation protocols in regulated environments

**Competencies and Attributes:**

- Demonstrated ability to function as a technical leader, generating original technical ideas and development strategies
- Possesses strong technical judgment and ability to work on problems of complex scope with competing factors
- Excellent ability to work collaboratively with diverse groups within engineering and maintain strong working relationships with internal and external partners
- Outstanding written and verbal communication skills with ability to clearly articulate technical challenges and solutions to stakeholders
- Demonstrated project management capability and ability to balance multiple priorities
- Proactive approach to identifying and resolving technical and project risks
- Self-motivated with ability to operate independently

**Key Stakeholders and Working Relationships**

- R&D team members (mechanical engineering, software engineering, systems engineering)
- Regulatory and Quality Assurance functions
- Operations and Supply Chain teams
- Clinical and Commercial teams
- External development partners
- Project management and cross-functional leadership

**Additional Information**

- Travel (domestic and/or international) may be required depending on project assignments (estimated 5%-10%)
- This role requires strong attention to detail and commitment to quality and regulatory compliance
- The successful candidate will demonstrate a passion for advancing innovative drug delivery technologies

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 short-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>)

Tris Pharma

Product Development Research Scientist II

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We have an immediate opening at our Monmouth Junction, NJ facility for two (2) Product Development (PD) Research Scientists II to join our Platform and Product Feasibility (PPF) team.

The PD Research Scientist II plans and executes pre-formulation and formulation activities, contributing to development of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC) thereby creating commercially viable intellectual property (IP). The incumbent also plans and executes pilot-phase process development activities and manufacture of current Good Manufacturing Practices (cGMPs) pilot batches, including all required documentation. The incumbent also collaborates with Analytical and Project Management to ensure project timelines and study milestones are met. She/he prepares technical reports including, but not limited to: feasibility reports, invention disclosures, early phase regulatory submission documents etc.

Primary responsibilities include:

- Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws
- Plans and executes pre-formulation and formulation activities with good scientific standards to assess feasibility of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC); generates supporting data for Intellectual Property (IP) and creates relevant invention disclosure forms
- Plans, coordinates and executes cGMP pilot batches, including protocols, master batch records and reports, under the guidance of senior staff
- Documents all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (GDPs) and cGMP; Summarizes data, discusses results and makes conclusions in technical reports
- Performs physical and chemical characterization in liaison with analytical teams
- Ensures cleanliness and functioning of lab areas and proper maintenance of equipment and instruments
- Collaborates with Analytical and Project Management to ensure project timelines and study milestones are met; Presents and updates project status and issues/challenges to management
- Collaborates with, and assists, Clinical Development with the coordination of pilot PK studies, including protocol review, submission of pilot batches to Contract Research Organizations (CROs), Pharmacokinetics (PK) data review and understanding
- Authors regulatory submission documents for Pre-Investigational New Drugs (Pre-INDs) and Investigational New Drug Applications (INDs), covering pre-formulation and formulation development
- Creates and revises SOPs, as needed
- Collaborates with Quality Assurance (QA) on investigations, Corrective Action Preventive Action (CAPAs) and Change Controls to ensure timely closure

Requirements

Required Qualifications:

- Masters degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND 3-5 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry OR
- Ph.D. degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND 0-2 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry REQUIRED
- Hands on experience in designing and conducting pharmaceutical formulation and process development studies with high scientific rigor, supporting multiple dosage forms (i.e., solid, liquid and/or extended release, etc.) REQUIRED
- Good understanding of Physical Pharmacy and Pharmaceutics REQUIRED
- Good technical writing skills, including SOPs, investigations, protocols, reports REQUIRED
- Working knowledge of Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), Drug Enforcement Administration (DEA), cGMPs and GLPs regulations and guidances REQUIRED

Anticipated salary range:

Masters degree and 3-5 years experience - $ 90 to $ 115K/yr.

PhD degree and 0-2 years experience - $ 85 to 110K/yr.

Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-office

New Jersey

Associate Director/Director, Regulatory Affairs Advertising & Promotions

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We have an opening in our Monmouth Junction, NJ office for an experienced Associate Director or Director, Advertising & Promotions to join our Regulatory Affairs team. Title and salary commensurate with experience.

This position provides senior regulatory oversight for the review and approval of promotional materials and related external communications for products. Reporting to the Head, Regulatory Affairs Advertising and Promotion, the incumbent helps ensure materials are accurate, balanced, substantiated, consistent with Food and Drug Administration (FDA) approved labeling and compliant with applicable FDA regulations, guidance, industry standards and company policies. She/he supports compliant business execution by providing strategic regulatory advice, leading complex promotional reviews, managing FDA submission requirements and improving review processes.

The incumbent serves as secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant and timely manner to meet company goals.

Primary duties/responsibilities

- Reviews and approves advertising and promotional materials ensuring compliance with applicable FDA laws, regulations and guidance documents

- Provides strategic input and clear regulatory advice towards the development of compliant yet competitive advertising and promotional material

- Key resource for regulatory advice on promotional and advertising initiatives throughout the company

- Maintains continued awareness and understanding of new and existing FDA regulations, guidance documents and enforcement actions regarding advertising and promotion of pharmaceutical products and communicates these to PRC and senior management, as needed

- Provides training regarding FDA expectations on advertising and promotion, as requested

- Provides strategic input on regulatory requirements for claim substantiation for desired promotional claims to enhance marketability of product portfolio

- Prepares and approves Form FDA-2253 submissions to OPDP

- Contributes to, and drives, Advertising and Promotion regulatory process improvements in relevant areas, as needed

Requirements

Special knowledge or skills needed and/or licenses or certificates required

Associate Director - PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 3 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED

-OR-

Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 7 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED

Director - PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 4 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED

-OR-

Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 8 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED

FOR ALL LEVELS:

- In-depth knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion and labeling REQUIRED
- Direct experience interacting with FDA OPDP REQUIRED
- Ability to influence without direct authority REQUIRED

Work Arrangements: We are a HYBRID work environment requiring candidates to be able to work majority of week in our NJ office.

Anticipated salary range:

Associate Director - $160 to 180K/yr.

Director - $185 to $230K/yr.

Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid

Insmed Incorporated

Executive Assistant, Global Clinical Development & Patient Advocacy

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

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

**About the Role:**

We’re looking for a Executive Assistant, Global Clinical Development & Patient Advocacy on the Clinical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Global Head of Clinical Development – Respiratory, you’ll also provide support to the VP, Patient Advocacy, and VP, Disease Area Head – Gene Therapy and other executives. The ideal candidate will be experienced in handling a wide range of administrative and executive support related tasks and will be able to work independently and proactively with little or no supervision.

**What You'll Do:**

In this role, you’ll have the opportunity to manage multiple calendars, schedule meetings, make travel arrangements, prepare expense reports, take notes and summarize meetings. You’ll also:

- Serve as an administrator to appropriate Team Channels, uploading files, keeping them up to date, and keeping the internal stakeholders informed
- Act as the main point of contact and coordination for all department Purchase Orders, statements of work, and invoice tracking and following the Procure to Pay process
- Proactively identify needs and gaps, and accordingly making proposals for improvement
- Have accountability for attention to detail and timely follow-up on assigned tasks
- Be responsible for coordinating invites, logistics, and execution of Townhalls and other team engagement events
- Support department projects and initiatives
- Develop, format, proofread and maintain upkeep of general Excel files, Word documents and PowerPoint presentations
- Coordinate with Legal and Compliance on managing Expert Service Agreements and any other contracts
- Have accountability for independently coordinating team meetings including logistics, food, travel, and other arrangements
- Set up, maintaining files and general correspondence

**Who You Are:**

You have a minimum of a High School diploma, with a Bachelor's degree preferred and a minimum of 5 years of Executive Assistant experience required, preferably supporting senior leaders in the Pharmaceutical or Biotech industry.

You are or also have:

- Experience supporting simultaneously multiple executives and ability to manage their needs as required
- Desire to learn and take on challenging assignments
- Ability to exercise discretion in dealing with confidential or sensitive matters
- Ability to handle multiple projects simultaneously while remaining flexible to shift priorities quickly
- Ability to excel in a fast-paced environment, sometimes under pressure, with a high level of professionalism is crucial to this role
- Professional etiquette in all aspects of the job
- Excellent calendar management skills
- Excellent communication skills (verbal and written).
- High level of organization with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

**Where You’ll Work**

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

**Travel Requirements**

Minimal travel expected

\#LI-TB1

\#LI-Hybrid

**Pay Range:**

$39.00-50.00 Hourly

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Director, Data Innovation & Strategy

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

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

**About the Role:**

We're looking for a Director, Data Innovation & Strategy on the Commercial Effectiveness team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Data Strategy and Innovation, you'll define and drive the Commercial data innovation strategy to enable measurable business value. You'll serve as the business owner of data and innovation use case identification, prioritization, value assessment, and governance across Commercial — partnering closely with Brand, Marketing, Field Strategy & Operations, Insights & Analytics, Data Management, and IT to ensure initiatives are aligned to business priorities, scalable, and compliant with governance standards

**What You'll Do:**

In this role, you'll have the opportunity to shape and lead the Commercial data and innovation agenda, driving meaningful impact for patients and the business. You'll also:

- Define and maintain the Commercial Data and Innovation roadmaps aligned to business strategy for each brand, establishing structured intake, evaluation, and prioritization frameworks for traditional and emerging data initiatives
- Serve as the strategic advisor to Commercial leadership on data innovation opportunities, risks, and competitive differentiation, re-imagining Commercial execution through data innovation and advanced analytics
- Identify and co-create high-value advanced analytics use cases across Commercial domains, prioritizing based on expected business impact and return on intelligence and investment
- Create business cases with clear value creation, success metrics, and investment requirements; define KPIs and measurable impact tracking frameworks for data innovation initiatives
- Monitor emerging data innovation, automation, and advanced analytics trends; identify, evaluate, and lead AI use cases from opportunity assessment through enterprise implementation and business adoption
- Design pilot programs and proof-of-value business initiatives in partnership with IT, establishing an innovation intake and incubation model within Commercial
- Partner with Brand, Marketing, Field Strategy & Operations, and Commercial leadership to understand key business challenges and introduce data innovation opportunities, extending successful initiatives across the organization where broader value exists
- Collaborate with IT Emerging Technologies and Data Platforms teams to ensure scalable, secure industrialization of new solutions, defining business requirements and value objectives for data and advanced analytics solutions
- Drive stakeholder adoption and change management to ensure capabilities are effectively utilized across Commercial, supporting advanced analytics literacy and business fluency initiatives
- Ensure data innovation initiatives comply with regulatory, privacy, and data governance standards; promote responsible and ethical data use and establish guardrails for model monitoring, bias detection, and lifecycle management

**Who You Are:**

You have a minimum**Bachelor's degree**in Data Science, Business Analytics, Economics, Engineering, or a related field, along with**8+ years of progressive experience**in pharmaceutical or biotech Commercial analytics, data strategy, and advanced analytics related roles, or a combination of education, training, and experience.

You are or you have:

- Experience identifying and operationalizing emerging data innovation and advanced analytics use cases in Commercial
- Understanding of Commercial data domains including HCP, HCO, claims, payer, promotional, specialty pharmacy, and patient data
- Experience partnering with IT to industrialize data innovation solutions within enterprise platforms
- Experience leading AI initiatives in partnership with business stakeholders and IT, translating business opportunities into scalable, production-ready solutions
- Experience influencing senior Commercial leadership and driving cross-functional transformation initiatives
- Familiarity with machine learning, predictive modeling, or automation applications
- Strong strategic thinking and structured problem-solving
- Ability to translate complex data innovation concepts into business value narratives
- Strong executive communication and stakeholder management skills
- Experience building multi-year capability roadmaps
- Financial acumen and ability to assess ROI
- Strong cross-functional influence skills

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

- MBA or advanced quantitative degree
- Rare disease, specialty, or respiratory experience
- Experience in launch environments, rare disease, or specialty markets

**Where You'll Work**

- This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.

**Travel Requirements**

- This role requires occasional domestic travel approximately 10%

\#LI-JT1

\#LI-Remote

**Pay Range:**

$177,000.00-242,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Nationwide

Director, Pharmacovigilance / Product Safety

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

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

**About the Role:**

We’re looking for a Director, Pharmacovigilance / Product Safety on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you’ll be the DSPV expert for assigned products; maintaining current knowledge of assigned product portfolio and safety profiles for products.

You will be responsible for safety surveillance, risk management, and risk communication for assigned development and marketed products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes.

**What You'll Do:**

In this role, you’ll have the opportunity to review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds. You’ll also:

- Be responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
- Have leadership of the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents such as Safety Signal Assessment Reports for assigned products and development compounds
- Lead the development and management of a comprehensive risk management system for risk detection, risk assessment and risk minimization for assigned products.
- Provide medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Work with the Head of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.
- Direct and collaborate on the development of product specific Risk Evaluation and Mitigation Strategy (REMS) in the event needed for assigned products.
- Ensure Risk Management System, Risk Management Plans (RMPs) for marketed and developmental products and Risk Minimization Measures (RMMs) are compliant with US, EU and International regulations and standards including ICH and EU GVP.
- Provide input into and support the writing of periodic reports for assigned products; provide medical interpretation, review and approval for required reports.
- Share DSPV and medical expertise on assigned products with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Medical Information, Marketing, Manufacturing, and Legal.
- Provide expert safety input to the clinical development program for assigned products and development compound.

**Who You Are:**

You have an MD or DO along with 2 years of Clinical Patient Care experience, 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products and 3 years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management. You are or also have:

- The ability to review and or prepare, scientific or regulatory documents, from large volumes of scientific information
- Knowledge and understanding of national & international PV and regulatory guidelines
- Ability to present drug safety topics for regulatory authorities at conventions, meetings, etc. Product defense before a national or international regulatory authority a plus
- Drug safety database knowledge preferred
- Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills

**Where You’ll Work**

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

**Travel Requirements:**

This position involves occasional US and domestic travel - up to 20%.

\#LI-TB1

\#LI-Remote

**Pay Range:**

$247,000.00-337,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Director, Product Communications

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

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

**About the Role:**

We are seeking a strategic and passionate Director, Product Communications to be responsible for communications for a leading product of Insmed's and lead the company's Patient Voices Program, with a primary focus on preparing for and executing a significant new indication launch for the brand.

The Director will sit on the brand Extended Global Program Team and partner closely with Global Program Head, commercial, clinical development, patient advocacy, and medical teams to design and execute communications strategies and plans, including disease state awareness, market prep, data communications, and regulatory milestones. The ideal candidate is a seasoned pharmaceutical communications professional with deep experience in patient storytelling, product launch, data communications, and rare disease – someone who can operate strategically while executing flawlessly in a fast-paced, high-stakes environment.

**What You'll Do:**

This role will be pivotal in shaping the narrative for our pipeline innovations and translating complex science into compelling stories that build understanding and momentum across key stakeholders including healthcare professionals, patients, media, and employees.

You'll also have these key responsibilities:

- **Communications Leadership:** Serve as the strategic communications partner for the brand, delivering sound, trusted communications counsel to the Global Program Team and sub-teams.
- **New Indication Launch Communications:** Lead the development and execution of a comprehensive communications strategy to prepare for and launch the potential new indication, including pre-launch market preparation, launch day activation, and post-launch momentum building.
- **Patient Storytelling & Patient Voices Program:** Champion and evolve Insmed's Patient Voices Program, serving as the primary communications steward for patient identification and storytelling.
- **Data & Regulatory Milestone Communications:** Lead communications planning and execution for clinical milestones – including data readouts, regulatory submissions, and approvals – ensuring clear, credible, and compliant dissemination of results to media and key stakeholders.
- **Disease State Awareness:** Drive initiatives that raise disease awareness among patient and HCP communities.
- **Cross-Functional Collaboration:** Work seamlessly with Commercial, Medical Affairs, Regulatory, Patient Advocacy, Investor Relations, Corporate Communications, and Corporate Brand/Digital Communications teams to ensure consistent, coordinated messaging across all channels and stakeholders.
- **Executive & Internal Communications:** Partner with Corporate Communications and leadership to keep employees informed and inspired around key milestones.

**Who You Are:**

You have a minimum of a Bachelor's Degree and 12+ years of progressive experience in brand or product communications

You are or you have:

- Pharmaceutical or biotech industry experience required; rare disease experience is highly preferred. A combination of agency and in-house experience is also highly preferred.
- Demonstrated expertise in patient storytelling, including experience identifying, developing, and managing patient spokespeople and partnerships.
- Proven track record in **product launch communications**, with experience building and executing pre-launch, launch, and post-launch communications plans.
- Strong data communications experience, including leading communications for clinical data readouts, regulatory milestones, and scientific publications.
- Disease awareness expertise, with the ability to build compelling campaigns that educate and engage diverse audiences around complex, underrecognized conditions.
- Deep understanding of pharmaceutical industry regulations and compliance requirements, including FDA promotional guidelines and fair balance requirements.
- Strong understanding of the healthcare media landscape and experience engaging with trade, scientific, consumer, and industry press.
- Proven ability to translate complex science into compelling narratives for diverse audiences – from patients and caregivers to physicians and journalists.
- Strong executive presence, with proven ability to fully integrate and participate in brand and leadership teams.
- Exceptional writing, storytelling, and presentation skills.
- Proficiency with AI-powered platforms and analytics tools, with demonstrated ability to integrate new AI technologies into existing workflows while maintaining regulatory compliance.

**Travel Requirements**

This role will require occasional domestic travel of approximately 10% based on business needs.

**Where You’ll Work**

This is a hybrid role based out of ourBridgewater, NJ Headquarters.You’llwork remotely most of the time, with in-person collaboration when it matters most.

\#LI-SK1

\#LI-SK - Hybrid

**Pay Range:**

$177,000.00-242,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Director, US Patient Advocacy & Professional Engagement

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

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

**About the Role:**

We’re looking for a Director, US Patient Advocacy & Professional Engagement to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Patient Advocacy, the Director, US Patient Advocacy & Professional Engagement will play a pivotal role in building and leading US-based patient advocacy and professional society engagements and collaborations, with a focus on Bronchiectasis and NTM Lung Disease.

The primary goal for this role will be to cultivate positive relationships with patient communities, advocacy groups, professional medical associations and individual patients, to better understand their needs, experiences, and challenges. This individual will be instrumental in providing the patient voice and perspective as we design and implement our clinical development programs. You will be the bridge between patients, patient organizations, and our organization, ensuring their perspectives influence our decision-making processes, clinical development strategies, and patient support initiatives. You will lead engagements with professional medical associations by setting the strategy and leading execution to evolve disease understanding and education.

**What You'll Do:**

In this role, you’ll have the opportunity to Develop and implement an External Partner engagement strategy aligned to internal business needs and external community needs. You’ll also:

- Partner with Patient Organizations to identify and implement innovative initiatives to empower patient communities to seek optimal and informed care.
- Participate in and support Patient Organization events, workshops, and conferences to elevate awareness and champion patient community engagement.
- Collaborate and co-create with Professional Medical Associations to identify and implement innovative initiatives and partnerships intended to address the evolving medical science related to Insmed’s therapeutic areas, as directed.
- Provide insight into Health Policy and Access & Reimbursement trends to ensure Patient Organizations have a thorough understanding of the access and reimbursement landscape.
- Implement a detailed framework to ensure patient experience is incorporated into all critical business decisions across the asset lifecycle.
- Engage with patient advocacy groups, foundations, and individual patients to see their point of view and needs as it relates to Patient-Focused Drug Development.
- Establish and maintain strong relationships with key collaborators in the patient community.
- Collaborate with cross-functional teams to ensure patient perspective is internally understood and incorporated into company culture and patient needs are considered at all stages of product development.
- Collaborate with Clinical Development, Medical Affairs, Regulatory, Corporate Communications, Human Resources, Legal, and Compliance to ensure that Insmed’s core values and corporate brand are represented in internal and external initiatives.
- Represent the company in external forums and conferences related to patient advocacy.

**Who You Are:**

You must have a Bachelor's degree in life sciences, healthcare, public health, or a related field and 10+ years’ experience in patient advocacy/engagement or closely related roles within the biotechnology and pharmaceutical healthcare industries. Additionally, you have:

- Deep understanding of respiratory conditions, including NTM Lung Disease and Bronchiectasis, with an ability to communicate complex scientific concepts to diverse audiences.
- Consistent track record of performance in developing and driving strategic projects, including leading budgets.
- Excellent communication and social skills to engage with patients, advocacy groups, and internal collaborators effectively.
- Experience working across multiple therapeutic areas and prioritizing appropriately.
- Demonstrated peer leadership experience and ability to inspire and motivate a matrixed team.
- Deep appreciation for patients and their families, with a passion for advocating on their behalf.
- Knowledge of regulatory and ethical considerations related to patient advocacy and engagement.
- Familiarity/experience with regulatory and pharmaceutical legal promotional review processes.
- Passionate for making a difference in the lives of patients with serious and rare disease.
- Acute organizational skills with a strong attention to detail, clarity, accuracy, and conciseness.

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

- Advanced degree (MBA, PharmD, PhD, MD) strongly preferred.

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasionaltravelfor team meetings or events may be expected.

**Travel Requirements**

This role requires occasional domestic travel (approximately 10-20%).

\#LI-MM1

\#LI-Remote

**Pay Range:**

$177,000.00-242,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Director, Talent & Workforce Strategy

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

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

**About the Role:**

The Director, Talent & Workforce Strategy shapes and leads Insmed’s enterprise approach to talent management processes, including talent reviews, succession planning, organizational design, and strategic workforce planning as Insmed evolves toward a future-focused skills-based approach.

This role helps build the future workforce by integrating enterprise talent strategy, Organizational Design, and Strategic Workforce Planning with skills-based organization design and data-driven insights — including emerging AI-powered solutions — to ensure the right capabilities and talent are in place.

Collaborating with global senior leaders as well as across all HR functions, this role will embed skills into career frameworks, role architecture, and workforce decisions, enabling a clear strategy for internal skill development, external talent acquisition, alternative talent models, and internal mobility.

The ideal candidate brings creative systems thinking, a future-focused mindset, a passion for AI and innovation, and the strategic perspective to translate complex talent frameworks into clear, actionable insights for leaders across the globe.

**What You'll Do:**

In this role, you will translate business strategy into capability-driven organizational designs, partnering with HRBPs to guide role evolution, team composition, and spans/layers aligned to future ways of working.

You will also have responsibility for:

- Own enterprise talent management processes,including talent reviews, succession planning, and critical role identification,evolving them from periodic events into continuous, data-enabled conversations integrated with business planning cycles.

- DriveStrategic Workforce Planning (SWP) in close collaboration with Financial Planning & Analysis (FP&A), conducting supply/demand and scenario analyses to surface capability risks, trade-offs, and long-term workforce needs.

- Assess and integrate emerging workforce trends,including the impact of AI and evolving work models,into talent and workforcestrategyto keep Insmedfuture-ready.

- Enable leaders and HR partners through the development of clear communications, toolkits, and guidance that support effective adoption of talent, skills-based, and workforce planning practices.

- Partner with People Analytics and People Operations toleveragedashboards and predictive insights that inform workforce capacity, capability, and risk decisions across the enterprise.

- Cultivate cross-functional partnerships across HR, Finance, and business leaders to embed skills into career frameworks, role architecture, and workforce decisions,enabling a clear path for internal mobility, external hiring, and alternative talent models.

**Who You Are:**

You have a Bachelor's degree in Human Resources, Organizational Development, Business, Industrial/Organizational Psychology, or other related field. Minimum 10 years of Human Resources Experience required, including 5-8+ years of related Talent Management, Workforce Planning, OD, or HR Business Partnership experience; prior experience in Pharma and/or Biotech a plus.

You are or you have:

- Experience designing and implementing novel talent system and process approaches.
- Background leading or supporting Strategic Workforce Planning, including scenario planning and skills-based forecasting.
- Strong understanding of organizational design principles, including job/role architecture, team design, and capability frameworks.
- Experience implementing AI-driven talent solutions.
- Strong analytical skills with the ability to translate data into insights, recommendations, and clear action plans.
- Strong consulting, facilitation, and communication skills with the ability to influence leaders at all levels.
- Experience using Workday or similar HRIS system(s).
- Experience managing, coaching, and developing direct reports while cultivating a high performing team preferred.
- Exceptional attention to detail and follow through, with ability to be flexible and adapt to in a fast-paced, evolving environment
- Ability to maintain a high level of confidentiality

**Must be commutable to Bridgewater, NJ Headquarters**

**Travel Requirements**

This role requires domestic travel of approximately 5- 10% based on business needs.

**Where You’ll Work**

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

\#LI-SK1

\#LI-SK - Hybrid

**Pay Range:**

$177,000.00-242,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

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

Medical Strategy Lead (NTM)

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

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

**About the Role:**

The Medical Strategy Lead (NTM) shall demonstrate excellence in medical science, strategy and operations. As a key contributor and collaborator, this position shall also demonstrate cross-functional leadership for the planning / execution of strategies / tactics of NTM programs (r-MAC and MAC-LD) consistent and cohesive to the overall corporate / GK objectives, Brand Plan and Japan Medical Affairs Plan (JMAP) throughout the life cycle of product. The individual in this position works in close collaboration and partnership with various internal business partners (Japan and global) and external stakeholders, including but not limited to, healthcare professionals (HCPs), medical/professional societies, government authorities and third-party vendors. This role requires a combination of program management, leadership by influence, strategic thinking, risk / change management, and deep knowledge / experience of modern Medical Affairs remit as well as the pharmaceutical industry's clinical and regulatory landscape.

**What You'll Do:**

- Excellence in strategy: Partner with Medical Affairs Leadership Team (MALT), Medical Affairs Team (AMAT), global / local internal business partners, including commercial partners, and external stakeholders to plan and execute GK Brand Plan, strategies / tactics defined in JMAP for product.
- Excellence in medical science: This individual shall gain and provide valued-added information and insights to internal and external stakeholders with in-depth and up-to-date understanding of product, its indications / therapeutic area and technologies to ensure high quality of science in all aspects of MA duties.
- Excellence in operations: In close collaboration with JMA teams and internal / external stakeholders, lead, manage and coordinate the development and implementation of JMAP. Ensure that the activities are planned and executed on-scope, on-time and on-budget in compliance with all applicable laws, regulations, policies/rules, SOPs and requirements.
- Expert Engagement and Scientific Exchange: Lead, manage, coordinate and facilitate engagement between internal and external stakeholders (e.g., Scientific Leader (SL), HCP, congress, medical / academic and professional society). Ensure fully compliant, professional and balanced exchange of scientific / medical and business information and insights. Gain scientific / medical and business insights and translate them to strategy / tactics planning and implementation.
- Competitive Intelligence (CI): Conduct CI to provide quality inputs and insights to the planning, execution and update of JMAP.
- Governance: Lead the review and decision processes locally (e.g., Japan Medical Review Committee (J-MRC), Japan Commercial Review Committee (J-CRC), Japan Grant Review Committee (J-GRC), JMA review of Medical Information Letter) and globally (e.g., Arikayce Medical Affairs Team (AMAT), Insmed Medical Affairs Research Review Committee (IMARRC), Integrated Evidence Team (IET) meeting).
- Clinical Development: Partner with clinical development functions, actively engage in clinical development strategy building, planning, including engagement with authorities such as PMDA and MHLW as well as medical review of clinical / regulatory documents (e.g., J-IND, J-NDA, J-PSUR). Support identification and selection of external medical experts. Support Clinical Trial Operations for their assessment of clinical sites and investigators as well as patient recruitment in clinical studies.
- In-house Medical Expert (a candidate with the license to practice medicine in Japan): Act as an internal medical expert to provided medical guidance and expert opinion to support Insmed activities including but not limited to drug safety and pharmacovigilance as well as product quality surveillance.
- Company Business: Partner with internal functions and external stakeholders to lead and support local business in Japan.
- People Management: When assigned, manage JMA staffs and teams/functions.

**Who You Are:**

- Minimum of 10 – 15 years of experience with the track record of success in Medical/Scientific Affairs in a pharmaceutical / biotechnology company in Japan in a global setting.
- Solid experience in managing cross-functional team consisting of both medical/scientific experts (senior level) and operational/administrative professionals.
- Experience in IND and NDA in Japan, NHI pricing negotiation, product launch excellence and life cycle management of pharmaceutical products in Japan is highly desired. Proven record of knowledge and experience in the field of pulmonary, infectious and/or cardiovascular diseases is strongly preferred. Additional experience in rare and/or neglected diseases may be a plus.
- Language: Native-level fluency in Japanese and high-level business fluency in English (very important).
- Ethics and compliance: Adherence to uncompromising ethical standards. Solid understanding of applicable local and global policies, rules and regulations as well as compliance policies and requirements of the pharmaceutical industry in Japan.
- Business acumen: Strong understanding of pharmaceutical business, including drug research and development, manufacturing, commercialization. Established strategic and logical thinking, and highly effective analytic skills. Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Communication/Presentation: Strong ability to quickly understand and dialogue on subjects that are at the interface between medicine and policy. Ability to connect science/medicine and unmet medical need to MA strategy. Excellent in disseminating and communicating complex scientific information and data in an impactful, balanced and user-friendly way. Excellent intra-personal and presentation skills (verbal and written, in Japanese and English) with the ability to effectively present ideas, and influence and negotiate with others to achieve desired goals.
- People: Works productively across local and global organizations as a team player. Ability to influence without authority.
- Must successfully exhibit Insmed core corporate value (Collaboration, Accountability, Passion, Respect and Integrity), Mission, Vision and Value Proposition of JMA along with any other position specific competencies.

**WhereYou’llWork**

This role is based out of ourTokyoofficewithweeklyflexibility to support both your professional and personal needs.

**Travel Requirements**

This role requires occasionaldomestic/international travel (approximately15%)

**Life at Insmed**

インスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイルに対応したフリーアドレス制を導入し、開放的で柔軟な働き方を実現しています。カフェエリアでは部門を超えた自由なコミュニケーションやコラボレーションを促進する空間を創り出しています。

日本法人の拠点として、患者さんにより良い医療をお届けするため、社員一同が一丸となって日々邁進しています。

社員一人一人の充実した働き方を実現するためのサポート：

• ワークライフバランスの実現

フレキシブルな勤務時間や充実した休暇制度

• 魅力的な報酬制度

退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会

• キャリア開発支援

社内研修、外部研修プログラムの活用、LinkedIn Learning、業務に特化した専門研修

• 先進的な学習支援

AI搭載の学習ツール、社内リソースへのアクセスを支援するデジタルアシスタント

• グローバルの表彰制度や従業員リソースグループ活動

• ハイブリッドワーク環境の整備

場所や時差を超えたシームレスな協働を実現する最新テクノロジー、充実したIT支援体制

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

*Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.*

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

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

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

Senior Manager, Global Medical Strategy & Communications Operations

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

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

**About the Role:**

We’re looking for a Senior Manager, Global Medical Strategy and Communications (GMSC) Operations on the Medical Affairs Strategy team to help us expand what’s possible for patients with serious diseases. Reporting to the Global Medical Lead, you’ll be responsible for maintaining systems and processes critical to the compliant and efficient execution of the global GMSC plans. GMSC is responsible for the development and delivery of internal and external medical strategies and related tactics. Critical operations functions within the team include facilitation of contracting and budget planning, and the development of project management tools, reports, and timelines for complex projects across the team. Activities include optimal departmental efficiency, consistency, and appropriate resource utilization.

**What You'll Do:**

In this role, you’ll have the opportunity to support the Global Medical Lead to ensure that the department develops and delivers tactics efficiently and consistently, while adhering to corporate policies and external regulations. You’ll also:

- Work with the medical directors and sci comms directors to develop and track budgets; facilitate contracting; participate in annual budget and forecasts
- Establish/maintain and lead training on data management systems that effectively support GMSC projects
- Work closely with the team to facilitate other administrative activities such as management and maintenance of folders, setting and maintaining meeting minutes and ensuring follow up actions completed
- Build reports based on identified departmental and corporate goals
- Proactively identify potential timeline risks, issues, and deviations from plans and budgets, and collaborate to implement solutions
- Assist in building and maintaining key meeting slides incorporating identified timelines and goals
- Build and maintain productive relationships with internal partners (Finance, Legal, Compliance, HEOR) and external vendors/agencies

**Who You Are:**

You have a Bachelor’s degree along with 5 years of experience in the pharmaceutical/biotech industry, primarily in Medical Affairs project management. You are or you also have:

- Strong organizational skills and the ability to manage multiple concurrent projects with competing priorities in a fast-paced environment
- Apply structured project management approaches (timelines, trackers, dashboards) to drive on-time, on-budget delivery
- Proficiency with Microsoft Office applications and document management systems (e.g. SharePoint, Veeva Vault, Smartsheets, etc.)
- Experience in determination of business requirements and launch of document management systems preferred
- Ability to manage external vendors and provide clear, concise direction
- Must have excellent communication skills (verbal and written)
- Strong attention to detail, clarity, accuracy and conciseness
- Demonstrated ability to work effectively within collaborative and cross-functional teams
- Must successfully exhibit Insmed’s five (5) core corporate values of: Collaborative Accountability, Passion, Respect and Integrity; along with any other position specific competencies
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

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

- Advanced degree preferred

**Where You’ll Work**

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

**Travel Requirements**

This role requires occasional domestic travel (approximately 10%)

\#LI-JK

\#LI-Remote

**Pay Range:**

$133,000.00-173,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Senior Director, Intellectual Property Strategy

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

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

**About the Role:**

We are seeking an accomplished and highly strategic patent attorney to lead the strategy for our non-small molecule patent portfolio. This role is designed for a senior expert who can operate at the intersection of sophisticated patent prosecution, patent disputes and competitive intelligence gathering. Reporting to the Chief IP Counsel, this individual will serve as our patent portfolio lead for all biologic programs within Insmed, with responsibility for developing and integrating global prosecution and challenge (both offensive and defensive) strategies. The role will function as a key strategic partner to the Chief IP Counsel, with a primary focus on strengthening the durability and value of Insmed’s protein therapeutics, gene therapy and antisense oligonucleotide assets worldwide, anticipating competitive threats, and identifying and mitigating vulnerabilities. The Senior Director, IP Strategy will work closely with research, CMC, development and broader product teams to harvest new inventions, draft patent applications, provide direction on prosecution strategy, and to perform IP due diligence activities. This position includes management responsibility for members of the IP team, such as those handling patent prosecution.

**What You'll Do:**

In this role, you will lead end-to-end IP strategy for our biologic patent portfolio, carefully integrating global prosecution and third-party considerations into a cohesive and forward-looking approach to maximize exclusivity positions.

You will also have responsibility for:

- Provide legal advice to cross-functional R&D and business teams on a variety of IP-related matters.
- Draft, file, and prosecute strategic patent applications worldwide both directly and through management of outside counsel and in house IP team.
- Play a central role in third-party challenges and challenge preparation, both offensively and defensively, while coordinating with outside counsel, including European oppositions and appeals, US post-grant proceedings (IPRs, PGRs), and litigation (e.g., US, Europe, China).
- Partner with the Chief IP Counsel on broader portfolio-level prioritization and risk assessment, while maintaining primary ownership of patent strategy.
- Drive competitor intelligence efforts and freedom-to-operate analyses, translating insights into actionable IP strategies.
- Identify gaps, risks, and whitespace opportunities across research and development programs, and ensure coordinated coverage and prosecution.
- Collaborate closely with internal subject matter leads and, where appropriate, provide mentorship or direct management to team members aligned with patent workstreams.
- Review manuscripts, presentations, press releases, corporate disclosures and other publication materials for clearance.
- Support business development, due diligence, and executive-level discussions as a subject matter expert in asset IP.
- Manage and direct outside counsel globally to efficiently deliver high-quality, strategically aligned work product.

**Who You Are:**

You hold a Ph.D. in a life science discipline in addition to a J.D. from an accredited US law school and member in good standing of a US State Bar. You will have15+ years of patent experience in the pharmaceutical/biotech sector, with significant in-house experience within a pharmaceutical/biotech company.

In addition you will have:

- Deep and creative expertise in patent prosecution strategy and implementation, including in viral gene therapy, protein therapeutics and antisense oligonucleotide technologies.
- Significant experience with patent disputes, including oppositions, IPRs/PGRs, and/or litigation.
- Demonstrated ability to integrate prosecution and dispute strategies into a cohesive, forward-looking IP approach.
- Strong understanding of global patent systems.
- Demonstrated successful experience advising senior management on complex IP issues, including risk assessment and strategic decision-making.
- Ability to operate as a senior individual contributor and strategic leader, with or without formal people management responsibilities.
- Superb technical, written and verbal communication skills in English.
- Ability to write well as evidenced by past patent applications and USPTO responses.
- Individual must possess initiative, high emotional intelligence and have strong interpersonal skills.
- Registered to practice before the US Patent and Trademark Office.

**Where You'll Work**

This is a hybrid role based either out of our Bridgewater, NJ or San Diego, CA office. You’ll work remotely most of the time, with in-person collaboration when it matters most.

\#LI-SK1

\#LI-SK - Hybrid

**Pay Range:**

$247,000.00-337,500.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Senior Manager, Technical Operations Strategy

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

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

**About the Role:**

We’re looking for a Senior Manager, Technical Operations Strategy on the newly formed Technical Operations Strategy team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Technical Operations Strategy, you’ll build from the ground up, work across manufacturing, supply chain, and Product Development (CMC Small Molecule, Large Molecule and Gene Therapy) to identify where strategic clarity is needed and go deliver it.

**What You'll Do:**

In this role, you’ll have the opportunity to work directly with Technical Operations leadership and functional leaders to define and advance the organization's most pressing strategic priorities.

You’ll also:

- Dig into complex, cross-functional questions, structure them clearly, and bring back a point of view. Identify where the thinking needs to happen and go do it
- Support manufacturing network decisions by developing scenarios, evaluating trade-offs, and helping leadership understand the long-term implications of site, supplier, and internal versus external manufacturing choices as programs move from clinical to commercial
- Build and maintain a clear picture of supply risk across the portfolio, identifying vulnerabilities and developing mitigation strategies and continuity plans that protect patient access
- Contribute to Product Development (CMC Small Molecule, Large Molecule and Gene Therapy) strategy by ensuring that early product development decisions and their downstream implications for manufacturing, supply, and commercial readiness are visible and accounted for in planning
- Support commercial readiness and launch planning by embedding supply continuity requirements early across the portfolio
- Build and leverage digital tools and data platforms to develop analytical models, dynamic dashboards, and live data integrations that make supply risk, network planning, and portfolio insights accessible and decision-ready
- Develop clear, concise materials that help leadership prioritize, escalate, and act across governance and portfolio-level discussions
- Build relationships at every level, within Technical Operations, across functions including Quality Assurance, Regulatory Affairs, Supply Chain, and Commercial, and with external partners
- Take on work that does not fit neatly into anyone else's lane and contribute to defining where this group can add the most value
- Perform other duties and special assignments as needed

**Who You Are:**

You have a Bachelor’s degree along with 5 years of experience in roles that required structured thinking, independent problem solving, and clear communication of complex ideas or a Master’s degree and 3 years of experience.

You are or you also have:

- Experience in strategy, business operations, project management, supply chain, or analytical functions within pharmaceutical, biotech, or life sciences
- Demonstrated ability to take an ambiguous problem, structure it, and deliver a clear recommendation without being told exactly how to get there
- Strong analytical skills and comfort working with data to build scenarios, assess risk, and support decision-making
- Excellent written and verbal communication skills. You do not need to be a polished presenter, but you do need to be able to communicate clearly and directly with senior leaders
- Proven ability to work independently and manage multiple priorities in a fast-moving environment
- Comfortable operating without a large team or established infrastructure behind you

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

- 7+ years of experience
- Experience in a strategy consulting, internal strategy, or business operations role, whether at a consulting firm or inside a pharma or biotech company
- Familiarity with supply chain risk, business continuity, or manufacturing network strategy
- Exposure to late-stage clinical or commercial launch planning in a regulated environment
- Experience supporting a portfolio of programs with shared dependencies, including complex modalities such as gene therapy
- Background in process improvement, operational excellence, or Six Sigma methodologies (Green Belt or Black Belt)
- PMP or equivalent project management experience

**Where You’ll Work**

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

**Travel Requirements**

This role requires occasional domestic/international travel (approximately 15-20%).

\#LI-HYBRID

\#LI-MC1

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Manager, Product Quality Complaint Data Analytics

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

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

**About the Role:**

The Manager, Product Quality Complaint Data Analytics, reports to the Director of Product Quality Complaints and is responsible for leading the governance, analytics, reporting, system support, and continuous improvement of Insmed's global Product Quality Complaint program. This role serves as the business and technical subject matter expert for complaint analytics, reporting, Veeva system enhancements, process improvements, and complaint surveillance.

The position is accountable for developing and maintaining the analytical framework used to identify product quality trends, evaluate complaint data, and support Management Review and executive decision-making. The Manager partners with Product Quality Complaints, QA Operations, Technical Operations, DSPV, Quality Systems, and Patient Services to support product quality investigations, implement system enhancements, and drive continuous process improvements.

The position will be based in Bridgewater, NJ HQ (onsite 3 days a week).

**What You'll Do:**

In this role, you’ll have the opportunity to lead the Product Quality Complaint Analytics function, including complaint analytics, reporting, metrics, trending, Veeva system support and enhancements, process improvements, and Management Review reporting.

You’ll also:

- Lead and manage the QA Sr Product Complaint Specialist, providing technical leadership, coaching, performance management, and professional development to direct reports. Establish team priorities, manage workload, allocate resources, and ensure timely completion of metrics activities and assigned projects.
- Support new product launch, and continuous improvement of Insmed's Product Quality Complaint Management process across clinical and commercial products, including complaint intake, evaluation, investigation, trending, and regulatory compliance for drug, device, and combination products.
- Establish and maintain statistical processes for complaint trending, action, and alert thresholds.
- Develop and maintain complaint analytics to support product performance monitoring, Management Review, and identification of potential quality trends.
- Support the development and implementation of automated reporting, data visualization, and other analytical tools.
- Oversee development and maintenance of KPIs and metrics supporting Product Quality Complaints Management Reviews.
- Provide technical support for signal detection activities and ensure identified quality signals are appropriately escalated through investigations, CAPAs, or product assessments, as applicable.
- Perform and/or oversee statistical analyses supporting complaint investigations, deviations, CAPAs, Management Review, and quality decision-making.
- Evaluate the effectiveness of CAPAs and quality improvements through product surveillance and trend analysis.
- Develop and maintain global surveillance procedures, work instructions, and quality system documentation related to product complaints supporting FDA, 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

**Who You Are:**

You have aminimumof a Bachelor's degree in related discipline as well as a minimum of 8 years of experience in Quality Assurance, Product Quality, Post-Market Surveillance, or Product Quality Complaint Analytics, including demonstrated experience in data analytics, metrics, reporting, and continuous improvement.

You are or also have:

- A minimum of 3 years of experience leading a highly collaborative team is required.
- Experience leading Post-Market Surveillance, Quality Engineering, or Product Quality activities in a regulated industry.
- Experience managing projects, technical staff, and cross-functional initiatives.
- Experience with complaint handling, investigations, trending, and product performance monitoring.
- Experience developing complaint metrics, statistical trending methods, and action/alert thresholds.
- Working knowledge of FDA Quality System Regulations, cGMPs, Good Documentation Practices, ISO 13485
- Experience supporting deviations, CAPAs, Management Review, and continuous process improvement.
- Experience with Veeva Vault QMS, Qlik, Minitab, or similar analytics tools, highly preferred.
- Excellent analytical, communication, organizational, and problem-solving skills.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

**WhereYou’llWork**

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

\#LI-hybrid

\#LI-EG1

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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