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    제약/바이오전문 1등 헤드헌팅사 나우팜컨설팅

    글로벌cro MW (1년 이상)

    페이지 정보

    등록자 : 강대필상무 21-02-19 09:20

    기본정보

    글로벌cro MW (1년 이상)

    임상

    사원~차장

    무관

    무관

    서류전형 -> 1차면접 -> 2차면접

    2021-02-19

    채용시

    상세정보

    본문

    [담당업무]
    - Prepare regulatory and clinical documents on behalf of Company in accordance with the ICH guidelines & international regulations
    - Write and edit clinical documents and submission to the sponsor
    Prepare protocols, clinical study reports, integrated summaries, all types of regulatory-agency submissions and medical writing as required
    - Analysis and interpretation of clinical trial data in medical points of view
    - Ensure quality of the documents & manage the document review process
    - Ensure there is appropriate compliances with GCP, SOPs, guidelines and regulatory requirements
    - Ensure compilation of appendices to trial reports
    - Participate in project team meetings to provide input regarding deliverables, timelines, and processes
    - Conduct literature searches, managing the literature database and prepare literature reviews for external and internal clients
    - Performs other duties as requested by management
    [자격요건]
    - MW I, II: Minimum 1 years~
    Sr. MW: Minimum 4 years  regulatory writing experience
    in clinical research, in healthcare, pharmaceutical CRO industry and/or related industry
    - Minimum bachelor degree (major in nursing, pharmacy, or other science-related background) from a recognized institution, and/or equivalent combination of training and experience
    - Qualified candidates must have experience writing protocols and protocol amendments, clinical study reports, investigator brochures, and all types of regulatory agency submissions
    - Solid knowledge of the clinical development process, Good Clinical Practices, and the Medical Writing process
    - Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature
    - Proficiency using an electronic document management system including MS office applications
    - Strong analytical ability to interpret clinical data