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