Associate Director, Medical Writer

A growing biopharma organization is seeking an experienced medical writing professional to support clinical and regulatory documentation across multiple therapeutic areas. This hybrid role offers flexibility and the opportunity to work from one of three locations: Danbury, Connecticut; Westlake Village, California; or Bedford, Massachusetts.

What You'll Do:

• Lead the development of clinical and regulatory documents including protocols, study reports, safety updates, and submission materials.
• Collaborate with cross-functional teams to ensure timely and accurate delivery of high-quality scientific content.
• Translate complex clinical data into clear, concise, and compliant documents for regulatory and scientific audiences.
• Contribute to strategic planning for regulatory submissions (e.g., INDs, NDAs, briefing documents).
• Maintain up-to-date knowledge of global regulatory guidelines and best practices.
• Support publication planning and development of abstracts, posters, and manuscripts.
• Help establish and refine templates, SOPs, and style guides to ensure consistency and quality.

What You Bring:

• Advanced degree in a scientific or medical field (Master's or PhD preferred).
• 5+ years of experience in medical writing within pharma, biotech, CRO, or academic settings.
• Strong understanding of ICH-GCP and global regulatory requirements.
• Excellent writing, editing, and project management skills.
• Experience across multiple therapeutic areas; endocrinology or pulmonology is a plus.
• Ability to manage multiple priorities in a fast-paced, collaborative environment.

Apply now and we can find a time to chat through more of the details.