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

Associates Degree (± 13 years)

Minimum 1 year experience