Senior/Principal Medical Writer

Key Responsibilities:

• Lead the preparation of complex clinical and regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Clinical Summaries in CTD format.
• Collaborate with clinical development teams, subject matter experts, and stakeholders to produce accurate, compliant documentation.
• Manage document timelines, review cycles, and project deliverables while ensuring quality standards.

Requirements:

• Several years of experience writing clinical regulatory documents in pharmaceutical or biotech industry.
• Proven experience as lead writer for multiple regulatory document types.
• 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 package aligned with experience level.