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