Job Title: Global Medical Expert
Location: Hyderabad/Mumbai, India
Job Type: Permanent, Full-Time
Posted: Jan. 03, 2025
Expires: Mar. 31, 2025
About the Job
Our Team:
Sanofi Business Operations is an internal resource organization based in India, centralizing processes to support areas such as Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital. We work to be a strategic partner, delivering functional support to global teams in Sanofi.
Main Responsibilities:
Collaborate with a team of medical regulatory writers to develop medical expertise in regulatory writing (content, methods, and processes).
Ensure compliance with regulatory requirements from various regions (FDA, EU, etc.) for activities supported.
Coordinate and support medical activities related to maintaining marketing authorizations for Established and Generic products across therapeutic areas.
Collaborate closely with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors.
Key Duties:
Provide medical assessments with updated clinical evidence for strategic documents such as PBRERs, ACOs, DSURs, and Benefit-Risk assessments.
Draft extended synopses of studies with RWE experts, overseeing execution in compliance with SOP, GCP, and regulations.
Write medical/clinical parts of Common Technical Documents (CTD) and Briefing Packages (BP).
Approve compassionate use medical requests for Sanofi medicinal products.
Ensure timely delivery of high-quality medical documents in compliance with standards.
Collaborate effectively with stakeholders in medical, regulatory, pharmacovigilance, and other related areas.
People:
Build relationships with stakeholders across medical, regulatory, and pharmacovigilance departments.
Assist the medical regulatory writing team in developing knowledge and sharing expertise.
Performance:
Ensure timely and high-quality deliverables (PBRER, ACO, SO, CSR, ID Cards, etc.) as per agreed timelines and quality standards.
Process:
Provide strategic insights and evaluations related to Sanofi’s portfolio.
Assist in managing marketing authorization dossiers.
Act as an expert in medical regulatory writing, maintaining regulatory requirements across countries.
Support medical teams in identifying writing needs and delivering customized medical documents.
About You
Experience:
≥5 years in supporting international pharmaceutical companies, with experience in medical affairs, clinical development, pharmacovigilance, and at least one therapeutic area (e.g., cardiovascular, oncology, CNS, anti-infectives, etc.).
Soft Skills:
Strong stakeholder management, communication skills, and the ability to work both independently and within a team.
Technical Skills:
Expertise in medical operational excellence, risk management, and excellent technical writing and editing skills.
Education:
Medical degree (MBBS, MD).
Languages:
Proficiency in English (spoken and written).
Why Sanofi?
At Sanofi, we are committed to creating a better world by progressing science and improving patient outcomes. We are looking for passionate individuals from diverse backgrounds to help us make the impossible possible. We provide equal opportunities to all, and we are dedicated to fostering diversity, equity, and inclusion.
Join Us:
Sanofi is evolving, and we want you to be part of that journey. Together, we can achieve extraordinary things and continue progressing towards better healthcare solutions.
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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