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 proceduresCoordinate activities which provide clinical, and scientific support to commercial functionsEnsure 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 applicableManage and monitor clinical trial environment and ensure impact of any changes is assessed and communicated to relevant local and corporate contractsManage internal TARC review and approval of all clinical activitiesLiaise with internal departments to obtain information required for clinical trial applicationsLead clinical trial applications through the regulatory system to assist in obtaining rapid approval for trial commencementProvide the required oversight to manage review, approval and conduct of IIS studiesContribute to the selection of investigators to undertake clinical trials as required and ensure patients recruitment strategy and contingency plan is in placeTrack and deliver agreed budgetPrepare 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 pipelinesSupervise 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 yearsUnderstanding of local regulation regarding CR/MISFamiliarity of medical terminology and product informationGood communication skills with internal and external stakeholders