About this role
MAIN PURPOSE OF THE ROLE Manages teams within the Medical Affairs Sub-Function. Focus is on policy and strategy implementation and control rather than development. Typically handles short-term operational/tactical responsibilities. MAIN RESPONSIBILITIES • As the Manager of the Medical Affairs Sub-Function, oversees the strategy implementation and operations for overseeing the direction, planning, execution, clinical trials/research and the data collection activities. • Contributes to implementation of clinical protocols, and facilitates completion of final reports. • Recruits clinical investigators and negotiates study design and costs. • Responsible for directing human clinical trials, phases III & IV for company products under development. • Participates in adverse event reporting and safety responsibilities monitoring. • Coordinates and provides reporting information for reports submitted to the regulatory agencies. • Monitors adherence to protocols and determines study completion. • Coordinates and oversees investigator initiations and group studies. • May participate in adverse event reporting and safety responsibilities monitoring. • May act as consultant/liaison with other corporations when working under licensing agreements.
QUALIFICATIONS Education Education Level Major/Field of Study or Equivalent Associates Degree (± 13 years) Experience/Background Experience Experience Details Minimum 7 years