Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D;, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
Main responsibilities:
Write and/or edit under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines.
Essential job duties and responsibilities: 1) Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3)



Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs teams based on the documents assigned.
· People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.
Performance: Provide deliverables (PBRER, ACO, Product and Disease ID Cards, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timeli

📌 Medical Regulatory Writer (Hyderabad)
🏢 Sanofi
📍 Hyderabad