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Medical Governance Officer 6 month contract

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Medical Governance Officer 6 month contract

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  • - Develop the Internal Assessment Plan and perform the Internal Assessment for activities in Medical and Regulatory area to enhance compliance and adherence with SOP/local regulations/other requirements
  • - Convene MaRG (Medical and Regulatory Governance) Country Committee to ensure overall management of country activities on MaRG dashboard
  • - Provide guidance and standard with respect to Medical & Regulatory processes based on learning, enhanced knowledge or changing circumstances (e.g. new regulations, SOPs etc.) on risk minimization activity
  • - Ensure Korea affiliate¡¯s audit preparation, conduct and response in Bayer system/corporate audit and for other required action(s) in collaboration with Legal/Code of Compliance Officer
  • - Responsible for LSRP role in Korea affiliate such as to maintain a Local Functions Network, to conduct Periodic Review for all listed LQS in QDoc with LQS Owner, to complete basic quality checks on all new or revised LQSDs prior to sending it to BHC R&D QSM (Quality System Management) for global review and so on
  • - Manage local e-learning training system (K-LEARN) for all staff of Bayer Korea

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  • [Education & training]
  •  Majored in pharmacy, nursing and medical science or equivalent
  •  Training related quality assurance in Scientific/Clinical Research area 
  • [Experience]
  •  3 or more years of pharmaceutical experience in R&D Quality or medical affairs or related fields
  • [Competency]
  •  Comprehensive knowledge of quality management, quality assurance, audit, spot-check and applicable legal / regulatory requirements
  •  Integrity, leadership, motivational, and interpersonal skills
  •  Capability of communication and negotiation with internal and external sectors such as global and region level, and Health Authority
  •  Proficient and effective verbal and written English communication skills
  •  Administrative, financial, and technical skills including computer skills (MS-word, Power point, Excel)

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  • - ´ç»ç ȨÆäÀÌÁö¸¦ ÅëÇÑ ¿Â¶óÀÎ Á¢¼ö

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  • - 2017.06.14 ~ 2017.06.30±îÁö

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