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    제약/바이오전문 1등 헤드헌팅사 나우팜컨설팅

    대기업.Clinical Research Physician - Rheumatology

    페이지 정보

    등록자 : 강대필상무 14-09-01 00:00

    기본정보

    대기업.Clinical Research Physician - Rheumatology

    임상

    팀장~임원

    무관

    무관

    서류전형 -> 1차면접 -> 2차면접

    상세정보

    본문

    Major Responsibilities The duties assigned to Clinical Research Physician are as follows:  Providing scientific and medical knowledge to generate clinical development plan (CDP) for each product in various stages of clinical development  Scientific & clinical discussion and negotiation on clinical development with major regulatory authorities including US FDA and EMA  Providing medical and scientific expertise for generation of clinical study protocols, data management plan, statistical analysis plan  Cooperative work on the preparation and execution of clinical trials with clinical development team and RA team  Medical consultation and decision making for ongoing clinical trials in therapeutic areas of expertise  Review and analysis of clinical study results and supervision of clinical study reports  Scientific support for IND & MAA process  Contribute to the training and education of medical and scientific issues for internal staff  Ensures that all established timelines and quality standards are met.  Supports SOPs, Good Clinical Practices, and all work processes to ensure an efficient and compliant clinical operation.  Works with clinical research personnel in reviewing laboratory data, performing physical assessments, medical histories, and evaluation of inclusion/exclusion criteria for study volunteers.  Liaises with the Hospital in their areas of expertise and joint projects.  Follow processes and adhere to Samsung and project specific standards as well as Health Authority requirements (SOP''s, Statistical Analysis Plan, GCP and regulatory guidelines).  Establish and maintain sound working relationships and effective communication within the Medical team and with other teams.