What are the responsibilities and job description for the Manager Medical Writing position at RBW Consulting?
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 :
