RBW Consulting is hiring: Manager Medical Writing in Boston

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, Investigator’s 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