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
Education Level
Associates Degree (± 13 years)
Experience/Background
Experience
Minimum 1 year
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