Remote Oncology Principal Medical Writer

Job is Expired
Location: Massachusetts
Compensation: To Be Discussed
Staff Reviewed: Thu, Aug 19, 2021

Job Summary

A vaccine and therapeutics development company has a current position open for a Remote Oncology Principal Medical Writer.

Core Responsibilities of this position include:

  • Formulating writing approach, developing timelines, and assessing resource requirements for key documents and regulatory submissions
  • Providing functional and cross-functional guidance on a wide range of issues related to document preparation
  • Collaborating with internal and external resources to achieve high quality, timely program level submission deliverables

Position Requirements 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
  • Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes

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