Senior Medical Regulatory Writer (Bogotá)

Senior Medical Regulatory Writer (Bogotá)

07 sep
|
Sanofi
|
Bogotá

07 sep

Sanofi

Bogotá

Senior Medical Regulatory Writer
- _ Location: Bogotá, Colombia _
- About the job_
- Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Senior Medical Regulatory Writer within our _Global Medical Services Team_, you’ll be _responsible for delivering high‑quality medical documents on time and in compliance with internal and external standards and guidelines. _

Main responsibilities:
- Deliver high‑quality medical and regulatory documents (PBRER, ACO, CSR, ID Cards, clinical evaluation reports, product alerts, trial transparency documents, etc.) on time and in full compliance with all standards and timelines.
- Participate independently in planning analyses and data presentations, ensuring high scientific and regulatory accuracy.
- Develop and maintain deep Therapeutic Area (TA) expertise to support content quality and scientific rigor.




- Review and provide constructive feedback on documents prepared by peer writers, ensuring consistency and excellence.
- Collaborate effectively with integral and local partners across Scientific Communications, Medical/Regulatory Writing, Pharmacovigilance, Regulatory Affairs and Corporate Affairs.
- Build strong relationships with medical and pharmacovigilance stakeholders and mentor junior writers by sharing knowledge and expertise.
- Ensure process excellence by authoring, reviewing, and maintaining regulatory‑compliant content, managing product alert documentation, tracking postings, and ensuring audit/inspection readiness.
- About you_
- Experience: Previous experience in regulatory writing for the pharmaceuticals/healthcare industry
- Soft skills:Stakeholder management, communication skills and ability to work independently/within a team environment
- Technical skills: Excellent writing and editing skills, with

📌 Senior Medical Regulatory Writer (Bogotá)
🏢 Sanofi
📍 Bogotá

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