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Location: Boston, MA Company: Mid-Sized Biotech Job Overview: We are seeking a highly skilled and motivated Manager/Senior Manager of Medical Writing to join our dynamic team at a growing biotech company in Boston. This individual will play a key role in the development and communication of clinical trial documentation, regulatory submissions, and scientific materials, contributing to our cutting-edge programs. The ideal candidate will have significant experience in medical writing, strong collaboration skills, and the ability to drive high-quality, regulatory-compliant deliverables. Key Responsibilities: Lead and manage the development of key regulatory documents including Clinical Study Protocols, Investigators Brochures (IB), Clinical Study Reports (CSR), and other essential clinical and regulatory documents. Collaborate with cross-functional teams (Clinical Operations, Regulatory Affairs, Biostatistics, and Research) to ensure that medical writing deliverables are aligned with regulatory expectations. Review and edit documents to ensure accuracy, consistency, clarity, and compliance with industry standards and regulatory guidelines. Will have the opportunity to mentor and train junior medical writers, providing leadership and support to ensure the quality and timeliness of medical writing activities. Qualifications: Master's or PhD highly preferred Minimum 5+ years of experience in medical writing within a Biotech or Pharmaceutical organization Strong experience writing and reviewing clinical trial documents such as protocols, CSRs, IBs, and regulatory submissions. Proven ability to manage multiple projects simultaneously and meet deadlines with a high level of attention to detail. Exceptional communication, writing, and editing skills, with the ability to distill complex scientific information into clear, concise, and compelling content. Ability to collaborate effectively in a team-oriented, cross-functional environment. Local to the Boston Area - this is a hybrid position