Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials. Knowledge of the pharmaceutical/biotechnology industry, including global drug development and regulatory processes, with particular knowledge of R&D, key clinical milestones, and the factors influencing critical development and decision-making points.