Job Title: Senior Medical Writer (Regulatory Writing)
Location: India (Global Hub)
Grade: L1-2
About the Job
Sanofi Global Hub, based in India, supports global operations across Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital functions. The Global Hub centralizes activities and processes to drive efficiency and collaboration. The Senior Medical Writer will play a key role in developing high-quality clinical and safety documents for regulatory submissions, supporting Sanofi's global medical and regulatory efforts.
Main Responsibilities
Clinical & Regulatory Writing
Write and/or edit complex clinical and safety documents for regulatory submissions, including:
Clinical Study Reports (CSR)
Clinical Trial Documents (CTD): Clinical overview (CO), Summary of clinical efficacy (SCE), Clinical safety (SCS), Clinical pharmacology (SCP), Biopharmaceutics (SBP)
Periodic Benefit-Risk Evaluation Report (PBRER)
Risk Management Plans (RMP), briefing packages, Immunogenicity reports, Product Alerts, Trial Transparency documents.
Ensure that all documents comply with internal and external regulatory guidelines and standards, delivered on time.
Team Leadership & Mentoring
Lead complex submissions and provide expert content guidance for medical sections of the CTD.
Act as a Subject Matter Expert (SME) and mentor to junior writers, ensuring high-quality content is delivered.
Review peer content, coach writers, and contribute to professional development in medical regulatory writing.
Collaboration & Stakeholder Engagement
Work effectively with multiple teams: Medical, Regulatory Writing, Pharmacovigilance, Clinical Trial Teams (CTT), Clinical Submission Teams (CST), Global Clinical Teams (GCT), and Safety Management Teams (SMT).
Maintain effective relationships with end stakeholders and support their regulatory needs.
Document Planning & Management
Participate in the planning of analysis and data presentations as part of the Clinical Trial Team (CTT).
Develop therapeutic area expertise and provide document-related advocacy to other teams.
Coordinate with internal teams to ensure timely and accurate document development and submission.
Process Improvement
Work with vendors and stakeholders to optimize document development processes.
Assist in the creation of customized deliverables based on stakeholder feedback and requirements.
About You
Experience
Minimum of 8 years of experience in regulatory writing within the pharmaceuticals/healthcare industry.
Soft Skills
Strong stakeholder management and communication skills.
Ability to work independently and as part of a team, including leading project teams and guiding junior writers.
Technical Skills
Expertise in global drug registration and regulatory submission processes.
Knowledge of clinical trial documentation, submission requirements, and therapeutic areas.
Project management experience is a plus.
Education
Advanced degree in Life Sciences, Pharmacy, or similar discipline (PhD, Master's, or Bachelor's in Science, D Pharma, Pharm D), or a medical degree (MBBS, BDS, BAMS, BHMS, MD).
Languages
Fluent in English (both written and verbal).
Why Choose Us?
Career Development: Opportunities for growth, promotion, and lateral moves.
Global Environment: Work with a diverse, international team driving innovation in healthcare.
Comprehensive Benefits: Enjoy a well-rounded benefits package, including health coverage, wellness programs, and parental leave.
Sanofi’s Vision: At Sanofi, we are committed to advancing healthcare through innovation, expertise, and collaboration. Join us to work alongside passionate professionals who strive to make a global impact by improving lives worldwide.
Equal Opportunity Employer
Sanofi is an equal opportunity employer that embraces diversity, offering opportunities to all regardless of race, gender, age, disability, or background.
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