Principal Medical Writer

Highly Competitive Salary
  1. Permanent
  2. Medical Communications, Medical Writing, Content Editor
  3. United States
Cambridge, USA
Posting date: 21 Aug 2023

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Principal Medical Writer for a cutting-edge pharmaceutical company located in Cambridge, MA.

As a Principal Medical Writer, you will be a vital member of their multi-disciplinary teams, contributing to the development of clinical documents in accordance with regulations, Good Clinical Practices, and SOPs.

Must be eligible to work in the US.

Job Responsibilities:

  • Craft high-quality clinical documents with precision and timeliness.
  • Lead independent development of critical documents, including efficacy and safety summaries, health authority briefing books, and consent forms.
  • Take charge of supplemental filings, Type 2 Variations, and global submissions.
  • Provide leadership and subject matter expertise to project teams, collaborating with Medical Writing line management.
  • Coordinate efficient review processes for internal and external documents, driving collaboration with diverse stakeholders.
  • Contribute to template development, process standardization, and staff training initiatives.

Skills and Requirements:

  • A Bachelor's degree in Life Science or English/Communications with relevant expertise.
  • Advanced degrees or certifications are a plus.
  • 7+ years of medical writing experience, including regulatory submissions exposure.
  • Knowledge of MW processes and standards, along with expertise in GCP, FDA regulations, ICH guidelines, and drug development.
  • A proven track record in managing multiple projects in fast-paced environments.
  • Proficiency in eCTD formatting, EDMS systems, and Microsoft Office tools.
  • Experience overseeing contract writers and unwavering attention to detail.

If you are having difficulty in applying or if you have any questions, please contact Dante Powell at +(1) 323-843-2059 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.