Job Title: Medical Regulatory Writer
Location: India (Hyderabad/Mumbai)
Job Type: Permanent, Full-time
Our Team:
Sanofi Business Operations is an internal resource organization based in India that centralizes processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. This team strives to be a strategic partner to Medical, HEVA, and Commercial teams at Sanofi globally.
Main Responsibilities:
Document Writing and Editing: Write and edit high-quality safety documents, including medical sections of Periodic Benefit-Risk Evaluation Reports (PBRERs), Clinical Overview Addenda, Disease and Product ID Cards, product alerts, and trial transparency documents. Ensure these documents meet internal and external standards and are delivered on time.
Collaboration: Work with Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, and other internal teams to ensure the development and delivery of regulatory documents as per business needs.
Medical Expertise: Develop and maintain expertise in the assigned therapeutic areas (TA) and ensure that documents reflect the most relevant and updated clinical evidence.
Key Duties:
Planning and Analysis Support: Assist in planning analysis and data presentation in collaboration with a mentoring medical writer.
Medical Regulatory Content: Collaborate with teams to produce and review medical content related to PBRERs, ACOs, Disease ID cards, study protocol amendments, clinical study reports, and more.
Stakeholder Management: Build and maintain relationships with stakeholders across various departments, such as Clinical/Medical teams, Pharmacovigilance, Regulatory Affairs, and others, to ensure alignment on deliverables.
Compliance and Process Management: Ensure that all deliverables comply with applicable regulatory requirements, and track progress to ensure audit and inspection readiness. Maintain and archive documents per company processes and regulatory standards.
Support in Managing Product Alerts: Review, prepare, and maintain stand-by statements (SBS QA) and manage product alerts as part of the product safety communication process.
Experience:
Skills:
Soft Skills: Strong stakeholder management, excellent communication skills, and the ability to work both independently and as part of a team.
Technical Skills: Proficiency in medical editing and writing, data interpretation, medical literature screening, knowledge of ICH and GCP/GVP guidelines. The ability to summarize complex scientific data and communicate it effectively to various audiences.
Education: Advanced degree in life sciences (M.Sc., Ph.D.), Pharmacy (B.Pharm, M.Pharm), or a Medical degree (MBBS, BDS, MD) is preferred.
Languages: Excellent command of the English language (written and spoken) is required.
At Sanofi, we strive for progress by embracing diverse perspectives and backgrounds. Our culture supports change and innovation, and we offer equal opportunities to all employees. Join us and be part of a company dedicated to making extraordinary things happen.
Diversity and Inclusion:
Sanofi values diversity and ensures equal opportunities for all, regardless of race, color, religion, gender, disability, or other status. Learn more about our Diversity, Equity, and Inclusion initiatives.
Apply now and pursue progress with Sanofi!
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