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Intern, Medical Writing Operations
at Vertex Pharmaceuticals Inc (US)
Boston, MA

Intern, Medical Writing Operations
at Vertex Pharmaceuticals Inc (US)
Boston, MA

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Description

Medical Writing Intern

About Medical Writing

The Medical Writing department is responsible for preparing clinical regulatory documents, including protocols, clinical study reports, New Drug Application submission modules, briefing materials, and Investigator's Brochures. The Associates group within the Medical Writing department performs advanced editing, fact-checking, and formatting (QC review) of regulatory documents. QC review ensures that a document is readable, accurate, consistent with source data, and adheres to Vertex editorial and formatting standards for submission documents. In addition, the Associates group is responsible for overseeing quality documents and systems, such as SOPs, guidelines, work instructions, and editing/writing software.

About the Medical Writing Intern Position

The Medical Writing Intern will work primarily with the Associates group to perform QC review of regulatory documents. The MW Intern will also work with medical writers and other functions within clinical development to learn about clinical studies, drug development, and regulatory guidelines.

MW Intern responsibilities may include:

* Performing content, editing, and formatting QC review on regulatory documents

* Assisting in coordinating and tracking clinical study report components

* Updating and reviewing checklists, SOPs, and templates

* Developing quick-reference training materials

* Assisting with QC process and software improvements

Minimum Qualifications

* Completion of 2 to 3 years of undergraduate coursework and currently enrolled in an undergraduate program in English or Science

* Strong writing and editing skills and knowledge of grammar

* Microsoft Word proficiency

* Attention to detail and ability to work independently

Preferred Qualifications

* Work or volunteer experience in editing, clinical trials, research, or biotech

* Advanced skills in Microsoft Word

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