Regional Medical Affairs Manager

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.

Education

Education Level Major/Field of Study or Equivalent Associates Degree (± 13 years)

Experience/Background Experience Experience Details Minimum 7 years