Principal Medical Writer
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.
- 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 email@example.com.
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.