Case Medical Strategy Lead

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 Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples 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 its 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 effecti Apply tot his job Apply To this Job