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Senior Lead, Global Compliance and Strategy
il y a 4 semaines
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 our company's compliance with regulatory requirements and developing strategies to drive business growth.
Key Responsibilities- Engage with local regulatory agencies in Japan to ensure our company's interests are represented in regulatory guidance documents and agency perceptions.
- Interact with customers to address quality and regulatory-related matters relevant to the use of technology in performing clinical trials.
- Collaborate with other departments to achieve our company's goals and business plan.
- Grow our Unified Protection Strategy in collaboration with Information Security, Data Privacy, and Cloud Operations.
- Balance project priorities and workload to ensure the team achieves overall customer-focused mission and objectives.
- Strong understanding of regulations governing clinical trials, including ICH Good Clinical Practices (GCP) and regional distinctions.
- Experience in clinical trial processes and technologies, including a working knowledge of trial master file and site master files (TMF/SMF) and eTMF.
- Understanding of 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.
- 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 with proven ability to present to corporate executives.
- Inspection management experience is a strong plus.
- Ability to travel expected at approximately 10%.
We offer a competitive base pay, commission on applicable plan documents, and annual bonuses. Our benefits package includes 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.
