Associate Director of Medical Writing

Job Summary

A company is looking for an Associate Director, Medical Writing.

Key Responsibilities

• Author, review, and manage clinical and regulatory documents
• Collaborate with internal teams and external vendors to manage timelines and deliverables
• Ensure documents comply with ICH guidelines, regulatory requirements, and company standards

Required Qualifications

• Advanced degree in life sciences (PhD, PharmD, or MS preferred)
• 8+ years of medical writing experience in the biotech/pharmaceutical industry
• Strong knowledge of ICH, FDA, and EMA guidelines
• Ability to work independently in a fast-paced, start-up environment
• Experience with StartingPoint templates, PleaseReview, and Microsoft Project is a plus