Senior/Principal Medical Writer

📋 Description

• Lead preparation of complex regulatory docs.
• Collaborate with clinical teams and SMEs.
• Provide guidance to clients and project teams.
• Manage timelines, reviews, and deliverables.
• Coordinate with writers, QA, and support staff.
• Monitor budgets and ensure timely delivery.

🎯 Requirements

• Several years of clinical regulatory writing experience.
• Lead writer for multiple regulatory doc types.
• Senior: lead 3+ projects; Principal: lead 5+ projects.
• Experience with CTD dossiers and CTD types desirable.
• Direct client and cross-functional team interaction.
• Strong regulatory docs knowledge and tools.

🎁 Benefits

• Fully remote with Europe-wide flexibility.
• Contribute to meaningful regulatory programs.
• Competitive compensation by experience.
• Standard benefits and professional development.
• Work with experienced writers and international teams.
• High ownership across regulatory projects.