Job Description
VIATRIS INNOVATION GMBH is a global healthcare company dedicated to delivering high‑quality medicines worldwide. We are seeking an Expert Medical Writer to lead and mentor a team of writers while producing high‑impact clinical and regulatory documents for global marketing applications.
Role & What You Will Be Doing
- Program‑level leadership – Lead, oversee, and coordinate medical‑writing deliverables for full CTD submissions across multiple development programs, ensuring scientific integrity, consistency, and on‑time delivery.
- Scientific & strategic contribution – Act as subject‑matter expert on regulatory requirements; provide guidance on data‑pooling, analysis plans, and document positioning to study and submission teams.
- Authoring / reviewing – Independently write or critically review CSRs, CTD Module2 documents, responses to agency questions, briefing packages, 120‑day safety updates, PIPs, investigator brochures, ...
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