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    Simon S. Kim
    Apr 27, 2021

    Global Compliance and Strategy APAC Lead

    in Current Job Openings

    [Company / Industry] Computer software & data solutions / Information Technology & Life Science

    [Position] Global Compliance and Strategy Lead

    [Function] Compliance and Strategy

    [Reporting Line] Director, Global Compliance and Strategy

    [Employment Type] Permanent

    [Compensation] TBD

    [Location] Seoul, Korea

    [Global HQ] New York, USA

    [Consultant in charge] Simon S. Kim


    COMPANY DESCRIPTION:

    Global data & solution company dedicated to life sciences / clinical trials market


    JOB DESCRIPTION:


    • Engage with key local regulatory agencies in the APAC region (e.g. MFDS (Korea), HSA (Singapore), TGA (Australia) etc.) and government authorities if applicable to ensure that the Company’s interest as a Software as a Service (SaaS) technology company serving regulated companies is considered in regulatory guidance documents and agency perceptions

    • Interact directly with customers to address quality and regulatory related matters relevant to the use of technology in performing clinical trials

    • Collaborate cross-functionally with other Company business units (e.g. Legal, Information Technology, Product Development) to contribute to achieving the Company's goals, business plan, and long-term strategy

    • Fulfill the responsibilities for providing operational support to Global Compliance and Strategy managed programs (e.g. quality incident management, internal quality system audits, customer audit/inspection needs)


    JOB REQUIREMENTS:


    [COMPETENCIES]

    • Strong understanding of regulations governing clinical trials, including:

    • Framework guidelines including ICH Good Clinical Practices (GCP) and regional distinctions

    • Clinical Regulations (e.g. KGCP, specific requirements in South Korea on Clinical trials, MFDS inspections)

    • Regulations on data management in clinical trials

    • Computer Systems Validation

    • Extensive experience in clinical trial processes and technologies, including, but not limited to a strong working knowledge of trial master file and site master files (TMF/SMF) and eTMF

    • Understands quality systems processes and enablement including auditing, root cause analysis and CAPA development

    • MFDS inspection experience is preferred

    • Proven track record of working independently to evaluate requirements and propose solutions

    • Strong teamwork spirit and good communication skills

    • Fluent (read, write, speak) in English and Korean

    • Residing in Seoul; able to travel within the region.

    [EDUCATION & EXPERIENCE]


    • Bachelor's degree required with 8 years of experience, 5 years of experience with a Master’s; or equivalent years of experience in the life sciences industry and/or medical/clinical operations

    • Requires a minimum of 2 to 3 years of experience in clinical development quality assurance.


    If you are interested, please contact simon.kim@rp4rp.com +82-2-6123-0100

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    3F KiWoom Yes Savings Bank Building, 422 NonHyunRo, GangNamGu, Seoul Korea 06223

    Tel +82-2-6123-0100   Fax +82-2-6123-0188   Email korea@rp4rp.com

    Recruitment License: International F1201220120010 / Domestic 2017-3220163-14-5-00040

    rightpersOn KOREA is a partner company of en world Group

    rightpersOn KOREA Inc. ​라이트퍼슨 코리아(주)