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

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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.

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Contributes to implementation of clinical protocols, and facilitates completion of final reports.

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Recruits clinical investigators and negotiates study design and costs.

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Responsible for directing human clinical trials, phases III & IV for company products under development.

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Participates in adverse event reporting and safety responsibilities monitoring.

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Coordinates and provides reporting information for reports submitted to the regulatory agencies.

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Monitors adherence to protocols and determines study completion.

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Coordinates and oversees investigator initiations and group studies.

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May participate in adverse event reporting and safety responsibilities monitoring.

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May act as consultant/liaison with other corporations when working under licensing agreements.

Education

Education Level: Associates Degree (± 13 years)

Experience/Background

Experience Details: Minimum 1 year