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