JOB DESCRIPTION:
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
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Medical & Scientific Affairs
DIVISION:
CRLB Core Lab
LOCATION:
Japan > Tokyo : Mita Twin Building West
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
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