Lead, Global Compliance and Strategy APAC
Dassault Systèmes Life Sciences Engagement team: empowering people and energizing passion to change the world and create the future.
Dassault Systèmes, with 35 years of experience transforming the way products are designed, produced and supported has combined with Medidata, developers of the world’s most-used platform for clinical development, commercial and real-world data. Our Life Sciences sales and marketing teams bring together all of Dassault Systemes life science capabilities in one go-to-market organization, providing our clients with life science domain focus and expertise to accelerate their business. As one organization we are leading the transformation in life sciences. Unique in the industry, we provide our clients with an integrated business and scientific platform from discovery and preclinical development, through clinical trials, all the way to manufacturing and commercialization. Discover the future of life sciences: www.mdsol.com
We know that diverse teams win and are fully committed to selecting leaders and employees that represent the markets in which we operate. Dassault Systemes Life Sciences & Healthcare, led by Medidata co-founder Tarek Sherif, has global operations and employees in the US, Europe and Asia.
Medidata is the leader in developing the technologies that allow our customers to get the medicines to patients faster. Building on our long history of delivering world-class clinical applications to the life sciences industry. The Life Sciences industry is globally one of the most highly regulated industries, regulated to ensure the utmost patient, safety, patient data security and patient privacy etc. To ensure Medidata is compliance and to pro-actively drive innovation, Medidata has a leading- and cutting-edge global compliance and strategy (GCS) department.
With Medidata’s continued growth in the Asia regions (including Japan, China, Korea, Singapore, and Australia), the ideal candidate will serve as a geographically local resource focusing on matters related to Medidata’s Quality Management System and regulatory strategy.
Enable both internal and external stakeholders to progressively enhance Medidata’s value proposition through the adoption of emerging clinical trial technologies while successfully meeting and navigating global regulatory expectations.
Reporting directly to the Director, Global Compliance and Strategy (“GCS”) APAC, the ideal candidate will:
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 Medidata’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 Medidata business units (e.g. Legal, Information Technology, Product Development) to contribute to achieving Medidata’s goals, business plan, and long-term strategy.
Fulfill the responsibilities for providing operational support to GCS-managed programs (e.g. quality incident management, internal quality system audits, customer audit/inspection needs).
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.
Your 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.
Dassault Systemes and Medidata are making a real difference in the lives of patients everywhere by accelerating critical drug and medical device research and development, manufacturing and commercialization, to enable life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of the most exciting areas for global innovation.
With Medidata’s record of more than 20,000 clinical trials giving us the largest collection of clinical trial data in the world, we also pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of insights to our clients, enabling them to make the decisions that allow them to reach waiting patients sooner.
Medidata Solutions Korea Ltd is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability or other factors that are unrelated to the legitimate business interests of Medidata Solutions.