Job Title: Senior Medical Writer – Regulatory Documents
Location: Sanofi Global Hub (India)
Department: Sanofi Global Hub
About the Job
Sanofi Global Hub is an internal resource organization based in India, designed to centralize and support processes for various business units such as Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital. Our goal is to act as a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial teams globally.
As a Senior Medical Writer in this role, you will be responsible for writing and editing high-quality safety and clinical documents such as Periodic Benefit-Risk Evaluation Reports (PBRER), Addendum to Clinical Overviews, Clinical Study Reports (CSR), Disease and Product ID Cards, and various other clinical evaluation reports. You will work independently with minimal supervision, contributing to key medical regulatory deliverables.
Main Responsibilities
Medical Writing & Documentation
Write and/or edit high-quality safety and clinical documents including:
PBRERs, Clinical Study Reports (CSR), Addendum to Clinical Overviews, Product Alerts, Trial Transparency Documents, and Disease/Product ID Cards.
Deliver documents on time and ensure they meet internal and external quality standards and guidelines.
Act as a mentor and peer reviewer, ensuring quality and consistency across written content.
Collaboration with Global Teams
Work closely with global teams in scientific communication, medical regulatory writing, pharmacovigilance, regulatory affairs, and corporate affairs to prepare and refine deliverables.
Maintain effective relationships with stakeholders within allocated business units and products, ensuring timely and accurate content development.
Stakeholder & Performance Management
Develop and maintain therapeutic area (TA) expertise to support high-level document creation and review.
Proactively liaise with cross-functional teams to identify and address medical writing needs.
Deliver PBRERs, ACOs, Briefing Packages, Product Alerts, and other relevant deliverables in compliance with agreed timelines and quality standards.
Process & Compliance
Ensure all documents comply with regulatory requirements for supported countries and regions.
Participate in the needs analysis and contribute to the design and implementation of medical regulatory plans.
Maintain compliance and audit-readiness by tracking and archiving relevant documents and content.
Review Product Alerts, prepare SBS QA documents, and ensure proper documentation for regulatory filings.
About You
Experience & Skills
>5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry.
Excellent technical (medical) writing and editing skills, with strong experience in summarizing scientific information for various audiences.
In-depth understanding of ICH, GCP, GVP guidelines, and regulatory processes.
Proficiency in data retrieval, scientific data interpretation, and medical literature screening.
Education
Advanced degree in life sciences, pharmacy, or related disciplines (PhD, Masters, Bachelor’s in Science, D Pharma, PharmD).
Alternatively, a medical degree (MBBS, BDS, BAMS, BHMS, MD) is also acceptable.
Soft Skills
Excellent communication skills with the ability to work independently and as part of a team.
Strong stakeholder management and vendor management abilities.
Ability to manage multiple priorities effectively and deliver results under pressure.
Languages
Fluent in English (written and spoken).
Why Choose Us?
Career Growth: Expand your professional development and career through exciting opportunities to work with global teams.
Global Impact: Join an innovative healthcare company with a strong focus on improving global health.
Work-Life Balance: Competitive compensation packages and benefits, including wellness programs, healthcare, and gender-neutral parental leave.
Sanofi’s Commitment to Diversity
At Sanofi, we are committed to providing equal opportunities to all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' to learn more about our inclusive work culture and Diversity, Equity, and Inclusion initiatives at sanofi.com.
Join us at Sanofi and help shape the future of healthcare through your expertise in medical writing and regulatory compliance. Let's pursue progress and discover extraordinary together!
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