R&D
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Job Title: Case Medical Strategy Lead

• Location: Morristown, NJ/Cambridge, MA

About the Job

Join our Patient Safety and Pharmacovigilance (PSPV) Operations team, as Case Medical Strategy Lead (CMSL) within the Case Management and Medical Evaluation Specialty Care Unit. 

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• The CMSL provides Case Management expertise, leadership, and mentorship (including product knowledge transfers) of relevant Therapeutic Areas case management members and Service Providers, to ensure appropriate management of cases and related activities.

• The CMSL deputizes for and assists the Case Medical Safety Lead, and is the key contact to internal and external stakeholders for specific Case management activities.

• The CMSL streamlines, supervises, and ensures consistent case medical oversight activities across GBUs, as developed by GBU Case Medical Safety Lead.

• In collaboration with the PV Operations Quality team, the CMSL develops and oversees the implementation of robust corrective and preventative actions (CAPAs) by Case Medical Safety Expert (CMSE).

• Represents the unit in transversal Case Medical oversight forums. 

• The CMSL is the focal point for the Case management GBUs on clinical trials and programs safety process expertise, by providing stakeholders and CMSEs with safety process expertise, ensuring harmonization across projects/Units, addressing with CMSE any safety reporting/flow issues by providing a strategic and proactive solution with having ability to communicate complex clinical issues. 

• The CMSL is the case medical expert working in collaboration with the CMSEs for audits and inspections.

• CMSL ensures strong collaboration and CMSE group representation with cross-functional groups within and outside the company (i.e. Therapeutic Areas, Clinical, Quality, Medical, Regional, Business Partners, CRO, Acquisitions and Divestments etc.). 

About you

​Education & Experience:

• MD or PharmD preferred; other healthcare professionals with adequate patient care experience can be considered (nurses, dentists, etc.)

• 8+ years of pharmacovigilance experience, or equivalent relevant pharmaceutical industry experience (clinical development, data management, etc.) where pharmacovigilance represents the primary focus.

•  Minimum of 3 years of project management/coordination experience, highly desirable.

Soft & Technical Skills:

• Thorough knowledge of Pharmacovigilance and Medical, Clinical processes and Regulations.

• Expertise of Pharmacovigilance databases and MedDRA coding.

• Ability to influence, demonstrate leadership and establish strong collaborations with cross-functional groups within and outside the company.

• Ability to persuasively communicate ideas and management vision regarding case management strategy in cross functional meetings and working groups.

• Demonstrates initiative and capacity to work under pressure.

• Ability to identify the need for AI use in their assigned activities.

Language:

• Fluent in English, able to communicate complex issues, medical and business concepts in English, both verbally and in writing. 

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.

Die endgültige Vergütung wird anhand verschiedener Faktoren festgelegt – zum Beispiel Erfahrung, Fähigkeiten, Fachkenntnisse, Standort und weiterer Kriterien.

Mitarbeitende können außerdem Anspruch auf die Teilnahme an unternehmensweiten Benefit-Programmen haben.