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

Associates Degree (± 13 years)

Minimum 7 years experience