Head of Medical Affairs – Pharma

JOB DESCRIPTION:

Primary Job Function:

• Manages and coordinates all activities related to clinical research and medical affair activities for both Abbott investigational and marketed products

Core Job Responsibilities:

• Manage the planning and execution of clinical studies in accordance with Abbott’s policies/procedures and local regulations.
• Ensure that all quality assurance activities within EPD Thailand are conducted according to local regulations and Abbott policies and procedures
• Coordinate activities which provide clinical, and scientific support to commercial functions
• Ensure all promotional materials are approved in line with Abbott’s policies/procedures and local regulations

Position Accountability / Scope:

CR

• Ensure all clinical activities are performed according to corporate, ethical, and legal requirements including GCP, GLP and GMP if applicable
• Manage and monitor clinical trial environment and ensure impact of any changes is assessed and communicated to relevant local and corporate contracts
• Manage internal TARC review and approval of all clinical activities
• Liaise with internal departments to obtain information required for clinical trial applications
• Lead clinical trial applications through the regulatory system to assist in obtaining rapid approval for trial commencement
• Provide the required oversight to manage review, approval and conduct of IIS studies
• Contribute to the selection of investigators to undertake clinical trials as required and ensure patients recruitment strategy and contingency plan is in place
• Track and deliver agreed budget
• Prepare reports on completed clinical trials as required, ensuring their accuracy, thoroughness and conformity with government regulations and the code of Good Clinical Practice

Medical Affairs

• Provide medical & scientific input for commercial strategies plans including pipelines
• Supervise overall MI activities

Minimum Education required:

Scientific related degree or equivalent qualification

Pharmacist preferred

Minimum Experience/Knowledge required:

• CR/MI related experience in pharmaceutical company is required for minimum 10 years
• Understanding of local regulation regarding CR/MIS
• Familiarity of medical terminology and product information
• Good communication skills with internal and external stakeholders

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:

EPD Established Pharma

LOCATION:

Thailand > Bangkok : Q-House Lumpini Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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