CMC Technical Writer in Korea

  • July 01, 2015 5:30 PM
    Message # 3416138
    Anonymous member (Administrator)

    Position Title: CMC Technical Writer

    Department: Quality Evaluation (QE) Team

    Reports To: Head of QE Team (VP)

    Position Summary: Technical writer of CMC documents on biopharmaceuticals for regulatory submission

    1.     Technical writing in English: SOPs, procedures, study reports, characterization reports

    2.     Technical writing in English: CTD Module 3 for CTA(IND) and MAA(BLA), Briefing book for regulatory meeting, responses to agency’s questions

     

    Requirements:

    Education: Scientific background in the area related to biology and/or biotechnology

    Experience: Experience on CMC technical documentation on biopharmaceuticals

    Preferred Skills: Understanding on protein drugs is preferable

    Other Requirement: Able to relocate to Korea and work within the company

                             Person unable to speak Korean is preferable


     

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    Consultant : 안 선 경 수석, 의료제약1팀

    Tel : 02-2286-3947  Mobile : 010-3289-7291  Fax :02)6008-3980

    Homepage : http://www.careercare.co.kr

    E-mail : ask@careercare.co.kr / guardianask@naver.com

    주소 : 서울시 강남구 삼성동 154-8 씨엔드에치빌딩 6층 (135-090)


    Last modified: July 01, 2015 5:30 PM | Anonymous member (Administrator)
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