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Senior Lead, Global Compliance and Strategy
Il y a 2 mois
At Dassault Systèmes, we're committed to powering smarter treatments and healthier people. Our company is a global leader in the life sciences industry, and we're looking for talented individuals to join our team.
About the RoleWe're seeking a Senior Lead, Global Compliance and Strategy to join our team in Japan. As a key member of our Global Compliance and Strategy team, you'll play a critical role in ensuring that our company meets and navigates global regulatory expectations. Your expertise will be essential in enabling both internal and external stakeholders to enhance our value proposition through the adoption of emerging clinical trial technologies.
Key Responsibilities- Engage with local regulatory agencies in Japan to ensure that our company'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 departments to help achieve our company's goals, business plan, and long-term strategy.
- Grow our Unified Protection Strategy in collaboration with Information Security, Data Privacy, and Cloud Operations.
- Balance project priorities, workload, and complete assignments to ensure the team achieves overall customer-focused mission and objectives.
- Fulfill operational support responsibilities for GCS-managed programs, including quality incident management, internal quality system audits, and customer audit/inspection needs.
- Understanding of regulations governing clinical trials, including ICH Good Clinical Practices (GCP) and regional distinctions.
- Clinical Regulations (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.
- 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.
- Demonstrated experience as a compliance functional expert with proven ability to present to corporate executives.
- Inspection management experience is a strong plus.
- Ability to travel expected at approximately 10%.
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.
We're an equal opportunities employer and welcome applications from diverse candidates. Applications will be accepted on an ongoing basis until the position is filled.
