Responsible for developing clinical protocols, Investigator's Brochures, informed consents and INDs/IMPDs. Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to regulatory...
Bulletproof Documentation, Inc.
CMC Report Writer
Scope of Work:
In support of preparation of the CMC sections of the BLA for Company biosimilar products, Bulletproof to provide two CMC report writers responsible to develop body of required CMC technical reports.