Senior Lead, Global Compliance and Regulatory Strategy
il y a 2 semaines
About Our Company
At Dassault Systèmes, we empower innovation and excellence in the life sciences industry. Our company is dedicated to powering smarter treatments and healthier people.
About the Team
We are seeking a highly skilled Senior Lead, Global Compliance and Regulatory Strategy to join our team in Japan. As a geographically local resource, you will focus on Medidata's Quality Management System and regulatory strategy, with a specific emphasis on the Japan market and region.
Key Responsibilities
- Engage with local regulatory agencies in the Japan region, including the PMDA and JPMA, to ensure Medidata's interests are 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, including Legal, Information Technology, Product Development, Sales, and 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, including quality incident management, internal quality system audits, customer audit/inspection needs.
Requirements
- Understanding of regulations governing clinical trials, including Framework guidelines, ICH Good Clinical Practices (GCP), and regional distinctions.
- Clinical Regulations, including 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.
- 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.
What We Offer
At Dassault Systèmes, we believe that benefits should connect you to the support you need when it matters most. We provide 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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