We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Main Responsibilities
Lead the development of an Integrated Medical Plan (MSLs, IME, Medical Communications and Publications, Health outcomes, Safety and Clinical Research (phase IIIB-IV and ISTs)) and annual budget for assigned brand(s).
Monitor the execution of the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables.
Communicate the details and progress of the Medical Plan to Management, the Core Team and all parties responsible for execution.
Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of a particular brand(s)/projects.
Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development.
Provide medical review or support to the medical designee for scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations.
Provide medical and scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations.
Provide medical review of applications for independent medical education grants.
Provide medical review of training materials for medical and commercial employees.
Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, CMJE, ISPOR).
Review, approve and supervise all aspects of US phase 111B - IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines and the accurate and timely reporting of study data.
Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH).
Review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s).
Identify and communicate Product Alerts to the Core Team (in conjunction with U.S. Drug Safety, USRAMP, GMA).
Partner with U.S. Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals.
Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within pertinent medical community.
Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development (in conjunction with RML).
Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc.
About you
Experience
Greater than 5 years relevant experience in Medical Affairs.
Advanced degree required (MD/DO, Pharm D, PhD)
Area of specialization: Experience in respiratory/allergy therapeutic areas preferred.
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.
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.
The salary range for this position is $195,000.00 - 260,000.00. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com
