Bangkok, THA
25 days ago
Head of Medical Affairs - Pharma
**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 An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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