Senior/Principal Medical Writer

📋 Description

• Lead the preparation of complex clinical and regulatory documents (Protocols, CSRs, CTD summaries
• Collaborate with clinical teams and stakeholders to produce accurate, compliant documentation.
• Provide document-specific guidance and strategic writing support to clients and project teams.
• Manage timelines, reviews, and deliverables to meet regulatory standards.
• Coordinate contributions from medical writers, QA, and supporting team members.
• Monitor budgets and ensure timely delivery within procedures.

🎯 Requirements

• Several years of experience writing clinical regulatory documents in pharma/biotech/healthcare.
• Lead writer experience for multiple regulatory document types (3+ of: Protocols, CSRs, CTD
• Senior level: lead more than three regulatory writing projects; Principal: lead more than five
• Principal: experience with multiple CTD dossier types (new chemical entity, variations, generics
• Experience working with clients and cross-functional teams, managing reviews and timelines.
• Strong understanding of regulatory documentation standards and document management tools.

🎁 Benefits

• Fully remote work environment with flexibility within Europe.
• Opportunity to contribute to meaningful clinical development programs.
• Competitive compensation aligned with experience.
• Standard benefits package and professional development opportunities.
• Work with experienced medical writing professionals and international teams.
• High ownership and responsibility across impactful regulatory projects.