Senior Lead, Global Compliance and Strategy, APAC
Japan - Tokyo
Medidata: Power Smarter Treatments and Healthier People
Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences, creating hope for millions of people. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Known for its ground-breaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. And Medidata’s ongoing commitment to infusing the patient voice into trial designs and solutions is helping to create a better and more inclusive experience for all participants in clinical studies. Medidata is involved in nearly 40% of company-initiated trial starts globally, with studies conducted in more than 140 countries. More than 70% of novel drugs approved by the Food and Drug Administration (FDA) in 2022 were developed with Medidata software. Medidata is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.comand follow us @medidata.
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 with a specific focus on the Japan market and region. 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 Japan region (e.g. PMDA, JPMA) 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, Sales, RFX) to contribute to achieving Medidata’s goals, business plan, and long-term strategy.
● Grow Medidata’s Unified Protection Strategy in collaboration with Information Security, Data Privacy and Cloud Operations and work closely with the Quality/Customer Management and Regulatory functions within GCS.
● Collaborate with GCS peers in the performance and delivery of day-to-day activities of the GCS organization.
● Balance multiple priorities, workload, and complete assignments to ensure the team achieves overall customer focused mission and objectives.
● 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. JGCP, specific requirements in Japan on Clinical trials, and PMDA 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.
● PMDA 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 Japanese.
● Based in Medidata’s Tokyo office.
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 trial processes and technologies, including a strong working knowledge of Quality Management Systems enablement.
● Strong understanding of regulations governing clinical trials including Clinical Regulations and Framework guidelines including ICH Good Clinical Practices (GCP).
● Demonstrated experience as a compliance functional expert (especially with regards to clinical processes and technologies) with proven ability to present to corporate executives.
● Inspection management experience is a strong plus.
● Ability to travel expected at approximately 10%.
● Able to work independently.
● Prior experience with a large central IRB or Ethics Committee is preferred.