Job Title: Medical Regulatory Writer
Location: Sanofi Business Operations (India)
Department: Sanofi Business Operations
About the Job
Sanofi Business Operations is an internal organization based in India, providing centralized support for several business units globally, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital functions. The team strives to be a strategic partner, delivering functional support for Medical, HEVA, and Commercial organizations within Sanofi.
As a Medical Regulatory Writer, you will be responsible for creating and editing high-quality safety documents and medical content, ensuring compliance with internal and external standards, and delivering on time to meet regulatory requirements. This role will support various global teams and departments in medical writing projects related to safety, regulatory documentation, and trial transparency.
Main Responsibilities
Medical Writing & Documentation
Write and/or edit high-quality safety and regulatory documents, including:
Periodic Benefit-Risk Evaluation Reports (PBRER)
Addendum to clinical overviews
Product and Disease ID Cards
Product Alerts
Trial Transparency Documents
Ensure the timely delivery of these documents, adhering to internal and external standards and guidelines.
Collaboration & Stakeholder Management
Collaborate effectively with scientific communication teams, medical regulatory writing teams, pharmacovigilance, regulatory teams, and corporate affairs teams to produce documents and ensure alignment on content.
Maintain strong relationships with stakeholders to facilitate the development of medical regulatory content as required by the global business units.
Process & Quality Assurance
Provide high-quality medical content in compliance with regulatory requirements for countries supported.
Work with external vendors to ensure the delivery of required content within the defined processes and timelines.
Track and archive materials in relevant systems, ensuring audit and inspection-readiness at all times.
Support & Development
Participate in the planning of analysis and data presentation to be used in regulatory documents, with initial guidance from senior medical writers.
Assist other medical writers in knowledge development and expertise sharing to improve quality and efficiency.
Review and maintain expertise in therapeutic areas (TAs), ensuring an up-to-date understanding of medical and regulatory trends.
About You
Experience & Skills
>2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry.
Excellent technical (medical) editing and writing skills, including experience in data retrieval, scientific data interpretation, and medical literature screening.
Knowledge of ICH, GCP, GVP guidelines, and regulatory requirements.
Strong skills in time and risk management.
Education
Advanced degree in life sciences, pharmacy, or a related discipline (PhD, Masters, or Bachelor’s in Science, D Pharma, PharmD), or a medical degree (MBBS, BDS, BAMS, BHMS, MD).
Languages
Fluent in English (written and spoken).
Soft Skills
Strong communication skills, with the ability to work independently and within a team environment.
Ability to manage relationships with stakeholders and external vendors effectively.
Why Choose Us?
Career Growth: Opportunities to develop your skills and advance your career in a dynamic and supportive environment.
Global Impact: Be part of an innovative healthcare company that makes a significant difference in the lives of people globally.
Work-Life Balance: Enjoy a competitive rewards package, with benefits such as healthcare and wellness programs, along with a focus on work-life balance.
Sanofi’s Commitment to Diversity
Sanofi is committed to providing equal opportunities to all employees, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Join Sanofi and contribute to shaping the future of healthcare through your expertise in medical regulatory writing. Let’s pursue progress together!
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