Director of Medical Writing

Job Summary

A company is looking for a Director of Medical Writing.

Key Responsibilities

• Prepare and manage complex clinical and regulatory documents and packages
• Lead the planning, development, and delivery of documents in compliance with ICH guidelines and company SOPs
• Manage and mentor medical writers, ensuring high-quality deliverables and professional development

Required Qualifications

• Minimum of a BSc with 12 years of experience in Medical Writing, or an advanced degree with 7 years of experience
• Experience with global regulatory submissions (e.g., BLA/NDA, MAA)
• Familiarity with ICH, FDA, and EMA guidelines and public disclosure requirements
• Proven experience in authoring documents and leading teams through the authoring process
• Strong project management skills with the ability to prioritize multiple projects