Edison-New Brunswick Metro Area, NJ
CMC Technical Writer
- 4 years of experience with CMC regulatory related activities. BS/BA or MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).
- The CMC Regulatory Technical Writer works closely with quality, manufacturing, regulatory, and technical staff from global locations
- Author high quality Module 2 and 3 CMC regulatory submissions for development and post-approval dossiers in eCTD format. The CMC Regulatory Technical Writer also authors change controls, following change control procedures.