Director, Medical Writing

Role: Lead medical writing activities across clinical development programs, ensuring high-quality regulatory and clinical documents. Responsibilities: develop and implement document strategies, author and review complex submissions, oversee outsourced writing support, and collaborate with cross-functional teams including Regulatory Affairs and Clinical Development. Ensure alignment with regulatory strategies, mitigate risks, and support successful filings. Qualifications: advanced degree (PhD, PharmD), 10+ years in medical writing or clinical research, with experience in major regulatory submissions such as NDAs, BLAs, or INDs; 2+ years in leadership or supervisory roles. HighValue: experience supporting global regulatory filings, complex submissions, and working across multiple therapeutic areas; knowledge of neuroscience preferred. WorkSetup: hybrid Waltham, MA, with at least 3 days onsite per week; not fully remote.