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.