Senior/Principal Medical Writer

📋 Description Lead preparation of complex regulatory docs (protocols, SRs, CTD summaries, IBs, IMPDs/INDs Collaborate with clinical teams and stakeholders for accurate, compliant docs. Provide document-specific guidance and strategic writing support. Manage timelines, reviews, and deliverables per regulatory standards. Coordinate contributions from writers, QA, and support teams. Monitor budgets and ensure timely delivery within procedures. 🎯 Requirements Several years’ experience writing clinical regulatory docs in pharma/biotech/healthcare. Lead writer for multiple regulatory doc types (at least 3 listed). Experience leading 3+ projects for senior or 5+ for principal level. Principal: CTD dossier experience desirable (NCE, variations, generics, orphan, literature). Direct client and cross-functional collaboration in review cycles and timelines. Strong knowledge of regulatory doc standards and tools. 🎁 Benefits Fully remote work environment with flexibility within Europe. Opportunity to contribute to meaningful regulatory programs. Competitive compensation aligned with experience. Standard benefits package and professional development. Work with experienced writers and international teams. High ownership and responsibility across regulatory projects.