MAIN PURPOSE OF THE 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.
Qualifications
Education
Associates Degree (± 13 years)
Experience/Background
Minimum 1 year
