Senior/Principal Medical Writer

📋 Description

• Lead complex regulatory documents (PS, CSR, CTD summaries, ICH/Investigator brochures, IMPDs/INDs)
• Collaborate with cross-functional teams to ensure accuracy and compliance
• Provide document-specific guidance to clients and project teams
• Manage timelines, reviews, and deliverables to meet regulatory needs
• Coordinate contributions from medical writers and QA staff
• Monitor budgets and ensure on-time delivery within procedures

🎯 Requirements

• Several years writing clinical regulatory documents in pharma/biotech/healthcare
• Lead writer for multiple regulatory document types (at least 3 of: protocols, CSR, CTD summaries
• Senior: lead more than three regulatory writing projects; Principal: lead more than five
• Experience with CTD dossiers (new chemical entity, variations, generics, orphan dossiers, or
• Direct client interaction and cross-functional teamwork managing reviews and timelines
• Strong knowledge of regulatory standards and document management tools

🎁 Benefits

• Fully remote work environment with Europe-wide flexibility
• 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