Clinical Affairs Specialist

JOB DESCRIPTION:MAIN PURPOSE OF THE ROLE

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.

QUALIFICATIONS:

Education

Associates Degree (± 13 years)

Experience/Background

Minimum 1 year

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Medical & Scientific Affairs:

DIVISION:

MD Medical Devices:

LOCATION:

Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable