Director of Medical Writing

Job Summary

A company is looking for a Director, Medical Writing.

Key Responsibilities

• Oversee cross-functional communication and deliverables for multiple projects, ensuring timely and high-quality document preparation
• Lead document review meetings and mentor less experienced medical writers
• Participate in process improvement initiatives and collaborate with regulatory teams for document submissions

Qualifications

• Master's degree in life sciences; PhD preferred
• 10+ years of regulatory writing experience in a pharmaceutical, biotech, or CRO environment
• Demonstrated success in preparing clinical and regulatory documents
• In-depth knowledge of industry regulations and ICH guidelines
• Expertise in MS Word, Excel, Adobe Acrobat, and experience with electronic document management systems