Director of Medical Writing

Job Summary

A company is looking for a Director of Medical Writing.

Key Responsibilities

• Lead and manage the writing, review, and finalization of clinical development and regulatory documents
• Innovate and streamline regulatory writing processes in collaboration with tech team members
• Ensure compliance of documents with regulatory agency guidelines and manage timelines for completion

Required Qualifications

• Bachelor of Science Degree required; advanced degree (MS or PhD) preferred
• 7+ years of experience in developing clinical and regulatory documents
• Experience as a lead writer for key clinical and regulatory documents
• Understanding of FDA/international regulations and ICH guidelines
• Experience mentoring or managing other writers preferred