Tokyo Abbott

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



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