Senior Medical Regulatory Writer

Sanofi Business Operations is an internal resource organization based in India, centralizing processes to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. It strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations globally.

Write and/or edit high-quality safety and clinical documents, including medical sections of Periodic Benefit-Risk Evaluation Reports, Addendum to clinical overviews, Clinical Study Reports, Disease and product ID Cards, clinical evaluation reports, product alerts, and trial transparency documents. Deliver high-quality medical documents on time and in compliance with internal and external standards and guidelines.

Work independently on documents with minimal supervision, act as buddy or mentor to medical writers, and efficiently peer review. Participate in planning analysis and data presentation, develop and maintain therapeutic area expertise, and review content created by peer writers. Collaborate effectively with global or local teams in Scientific communication, Medical regulatory writing, Pharmacovigilance, Regulatory, and Corporate Affairs.

Maintain effective relationships with end stakeholders in the medical scientific community to develop medical regulatory content. Author, review, and act as expert in medical regulatory writing while maintaining regulatory requirements for supported countries. Track postings, file or archive material in relevant systems, and ensure audit and inspection-readiness.