[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 firstname.lastname@example.org +82-2-6123-0100