Job Description

Our client is a biotech company with an alternative drug development approach to achieving human-proof-of-concept (hPOC) that is intensely focused on minimizing time, risk, and cost while maximizing efficiency and probability of success.

They are in need of an experienced regulatory writer with oncology experience for the following:

- Protocol synopsis,
- FDA meeting request and meeting package
- Protocol and ICF - Investigator Brochure update

It is expected this project will begin in mid/late May and continue for 4-5 months. A timeline schedule and additional info will be provided to qualified writers. All work can be done remotely.