Senior/Principal Medical Writer

📋 Description Lead preparation of regulatory docs: protocols, summaries, IBDs, IMPDs/INDs, publications Collaborate with clinical teams and stakeholders for robust documentation Provide guidance and strategic writing support to clients/projects Manage timelines, reviews, and deliverables to meet regulatory standards Coordinate contributions from medical writers and QA specialists Monitor budgets and ensure on-time delivery within procedures 🎯 Requirements Several years writing clinical regulatory documents in pharma/biotech/healthcare Lead writer on multiple regulatory document types (3+): protocols, reports, CTD summaries, IBDs Senior: lead >3 regulatory writing projects; Principal: lead >5 projects Principal: CTD dossiers experience (NCE, variations, generics, orphan, literature-based) Direct client and cross-functional team interaction; manage reviews and timelines Strong regulatory documentation standards and document management experience 🎁 Benefits Fully remote within Europe 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