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
