Remote Principal Medical Writer in Lexington

Location: Massachusetts

Compensation: To Be Discussed

Staff Reviewed: Tue, Jul 13, 2021

This job expires in: 17 days

Job Category: Writing

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors, Masters

Job Summary

A vaccine and therapeutics development company is seeking a Remote Principal Medical Writer in Lexington.

Core Responsibilities of this position include:

  • Working across therapeutic areas to provide expert support as needed
  • Assuming primary responsibility for preparation of key clinical and regulatory documents and documents supporting major regulatory submissions
  • Formulating writing approach, developing timelines, and assessing resource requirements for key documents and regulatory submissions

Qualifications Include:

  • Bachelor’s degree
  • At least 7 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company
  • Experience as lead writer for key documents included in major US and/or international regulatory submissions
  • Ability to understand the company's guidelines and requirements related to the preparation and production of regulatory documents and submissions
  • Understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment
  • Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production

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