Senior/Principal Medical Writer

📋 Description Lead complex regulatory documents (PS, CSR, CTD summaries, ICH/Investigator brochures, IMPDs/INDs) Collaborate with cross-functional teams to ensure accuracy and compliance Provide document-specific guidance to clients and project teams Manage timelines, reviews, and deliverables to meet regulatory needs Coordinate contributions from medical writers and QA staff Monitor budgets and ensure on-time delivery within procedures 🎯 Requirements Several years writing clinical regulatory documents in pharma/biotech/healthcare Lead writer for multiple regulatory document types (at least 3 of: protocols, CSR, CTD summaries Senior: lead more than three regulatory writing projects; Principal: lead more than five Experience with CTD dossiers (new chemical entity, variations, generics, orphan dossiers, or Direct client interaction and cross-functional teamwork managing reviews and timelines Strong knowledge of regulatory standards and document management tools 🎁 Benefits Fully remote work environment with Europe-wide flexibility Opportunity to contribute to meaningful clinical development programs Competitive compensation aligned with experience Standard benefits package and professional development Collaborate with experienced medical writing professionals and international teams High ownership and responsibility across regulatory projects