Senior Lead, Global Compliance and Strategy
About our Company:
Medidata: Powering 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 groundbreaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. 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.com and follow us on LinkedIn, Instagram, and X.
About the Team:
With Medidata's continued growth in the Asia regions (including Japan, China, Korea, Singapore, and Australia), you will be a geographically local resource focusing on 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 meeting and navigating global regulatory expectations. Reporting directly to the Director, Global Compliance and Strategy ("GCS") APAC, you will:
- Engage with important 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 with other Medidata departments (e.g. Legal, Information Technology, Product Development, Sales, RFX) to help achieve 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 with the Quality/Customer Management and Regulatory functions within GCS.
- Collaborate with GCS peers in the performance and delivery of daily activities of the GCS organization.
- Balance project 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).
- This is an individual Contributor role.
Responsibilities:
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.
- Experience in clinical trial processes and technologies, including a working knowledge of trial master file and site master files (TMF/SMF) and eTMF.
- Understand quality systems processes and enablement including auditing, root cause analysis and CAPA development.
- PMDA inspection experience is preferred.
- This is a stand alone position in Japan office .
- Native level Japanese (read, write, speak) and fluent English.
Qualifications:
- 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%.
- Prior experience with a large central IRB or Ethics Committee is preferred.
Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, life and disability insurance; paid time off; paid sick leave; Employee Assistance Program; and paid parental leaves.
Applications will be accepted on an ongoing basis until the position is filled.
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MEDIDATA는 제약, 생명공학, 의료 기기 및 진단 회사, 학술 연구자들이 빠르게 가치를 실현하고 최소한의 리스크로 최적의 결과를 얻을 수 있게 하는 증거와 통찰력을 생성합니다.