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Job Description
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 .