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.

QUALIFICATIONS

Education

Education Level : Associates Degree (± 13 years)        

Experience/Background

Experience : Minimum 1 year