Associate Director, Medical Writing

We are seeking an Associate Director, Medical Writing to support the development of high-quality clinical and regulatory documents. The role involves leading critical documents from start to finish, collaborating with cross-functional teams, and ensuring timely and compliant document delivery.

Requirements

• Advanced degree in life sciences (PhD, PharmD, or MS preferred)
• 8+ years of medical writing experience in the biotech/pharmaceutical industry, including regulatory submissions
• Strong knowledge of ICH, FDA, and EMA guidelines
• Excellent writing, editing, and project management skills
• Ability to work independently in a fast-paced, start-up environment
• Ability to work collaboratively and coordinate the efforts to resolve comments with team members
• Flexible and able to adapt to changing deadlines and priorities
• High attention to detail