Senior/Principal Medical Writer

📋 Description

• Lead preparation of regulatory documents (Protocols, CRs, CTD summaries, IBs, IMPDs/INDs
• Collaborate with clinical teams to ensure accuracy and regulatory compliance.
• Provide document-specific guidance to clients and project teams.
• Manage timelines, reviews, and deliverables; ensure quality and regulatory standards.
• 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 (≥3 types).
• Senior: lead >3 projects; Principal: lead >5 projects.
• Principal with multiple CTD dossier types is desirable.
• Experience with client interaction, authors, cross-functional teams.
• Strong regulatory writing skills and document management familiarity.

🎁 Benefits

• Fully remote work environment with Europe-wide flexibility.
• Opportunity to contribute to meaningful regulatory programs.
• Competitive compensation aligned with experience.
• Standard benefits package and professional development.
• Collaborate with experienced medical writers and international teams.
• High ownership and responsibility across regulatory projects.