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Last Name*

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Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

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Job type: Permanent

Discipline: Medical Communications, Medical Writing, Content Editor

Location: United States

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 d.powell@proclinical.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.

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