MAIN PURPOSE OF ROLE
- Experienced professional individual contributor that works under limited supervision.
- Applies subject matter knowledge in the area of Medical Affairs.
- Requires capacity to apply skills/knowledge within the context of specific needs or requirements.
MAIN RESPONSIBILITIES
As the Experienced professional in the Medical Affairs Sub-Function, possesses well developed skills in 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: Associates Degree (± 13 years)
Experience/Background
Experience: Minimum 1 year
