Senior Medical Regulatory Writer
Sanofi, MD, United States
Senior Medical Regulatory Writer
Apply locations Hyderabad time type Full time posted on Posted 9 Days Ago time left to apply End Date: January 30, 2025 (30+ days left to apply) job requisition id R2771146
About the job
Our Team:
Sanofi Global Hub is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
Main responsibilities:
- Write and/or edit high-quality safety and clinical documents, including medical sections of Periodic Benefit-Risk Evaluation Reports, Clinical Study Reports (CSR), and clinical evaluation reports.
- Deliver high-quality medical documents on time and in compliance with internal and external standards and guidelines.
- Work independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer review.
- Participate independently in the planning of analysis and data presentation.
- Develop and maintain TA expertise.
- Review content created by peers’ writers.
- Collaborate effectively with Scientific communication teams, Medical regulatory writing teams, Pharmacovigilance teams, Regulatory Teams, and Corporate Affairs Teams.
- Maintain effective relationships with stakeholders in the medical scientific community.
- Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, etc.) as per agreed timelines and quality.
- Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
- Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness.
About you
- Experience: >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry.
- Soft skills: Stakeholder management, vendor management, communication skills, and ability to work independently and within a team environment.
- Technical skills: Excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, knowledge of ICH and GCP/GVP.
- Education: Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree.
- Languages: Excellent knowledge of the English language (to read, write, and speak).
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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