Job Title: Medical Writer (Regulatory Writing)
Location: India (Sanofi Global Hub)
Grade: L1-2
About the Job
Sanofi Global Hub, based in India, centralizes processes to support global functions in Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital. As part of this hub, you will play a crucial role in developing and editing medical documents for regulatory submissions. The Medical Writer will contribute to the timely preparation of high-quality clinical and safety documents to meet regulatory requirements and ensure compliance.
Main Responsibilities
Document Creation & Review
Write and edit high-quality safety and clinical documents, including:
Periodic Benefit-Risk Evaluation Reports (PBRER)
Addendum to Clinical Overview (ACO)
Clinical Study Reports (CSR)
Disease and Product ID Cards
Clinical Evaluation Reports
Product Alerts and Trial Transparency documents
Ensure compliance with internal and external standards and guidelines, and deliver documents on time.
Collaboration & Stakeholder Engagement
Work closely with internal teams like Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, Clinical Teams, and Corporate Affairs to prepare required deliverables.
Mentor junior medical writers and collaborate effectively across regions to ensure quality output.
Process & Planning
Participate in planning the data analysis and presentation for medical documents.
Assist in developing therapeutic area expertise and provide document-related advocacy to other teams.
Maintain regulatory expertise for assigned countries and ensure timely delivery of documents according to the plan.
Quality & Compliance
Ensure audit and inspection-readiness of all medical documents.
Maintain and track postings and document submissions (e.g., trial protocols, amendments, study results, and redacted documents) on relevant platforms such as CTG (clinicaltrials.gov), EUCTR, EUDRACT.
Stakeholder Relationships
Build and maintain strong relationships with key stakeholders within Sanofi, including Clinical/Medical, Pharmacovigilance, Biostatistics, Regulatory, and Legal teams to ensure smooth communication and accurate content delivery.
About You
Experience
5+ years of experience in regulatory writing within the pharmaceuticals/healthcare industry.
Soft Skills
Strong stakeholder management and vendor management abilities.
Excellent communication skills with a capacity to work independently and as part of a team.
Ability to handle multiple priorities and complex writing assignments.
Technical Skills
Expertise in medical editing and scientific data interpretation.
Strong knowledge of ICH, GCP/GVP, and ability to summarize and edit scientific information for diverse audiences.
Proficient with data retrieval, medical literature screening, and computer applications.
Education
Advanced degree in Life Sciences, Pharmacy, or related field (PhD, Master's, or Bachelor's in Science, D Pharma, Pharm D), or medical degree (MBBS, BDS, BAMS, BHMS, MD).
Languages
Fluent in English (both written and verbal).
Why Choose Us?
Career Development: Opportunities to grow within a global, diverse, and collaborative environment.
Impact: Be part of a team that drives innovation in healthcare and contributes to improving lives worldwide.
Comprehensive Benefits: Competitive benefits including health coverage, wellness programs, and parental leave.
Sanofi’s Vision:
We believe that progress in healthcare happens when people with diverse backgrounds work together. Join us and be part of a team that fosters innovation and strives to make a difference in the world.
Equal Opportunity Employer
Sanofi is committed to diversity and equal opportunity, providing opportunities to all individuals regardless of race, gender, age, or background.
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