MAIN PURPOSE OF ROLE

Specialist professional individual contributor with comprehensive knowledge in the area of Medical Affairs.

Ability to execute highly complex or specialized projects.

Adapts precedent and may make significant departures from traditional approaches to develop solutions.

MAIN RESPONSIBILITIES

•As the Specialist in the Medical Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization 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

Associates Degree (± 13 years)

Experience/Background

Minimum 7 years