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Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps plein{"Role Description & Responsibilities": "Unlock your potential with Dassault Systèmes, a global leader in Scientific Software EngineeringAs a License Compliance Investigator, you will be responsible for:Assisting the Manager in developing the supporting infrastructure necessary for the effective growth of the License Compliance Program, with a focus on...
Senior Lead, Global Compliance and Regulatory Strategy
Il y a 2 mois
We are seeking a highly skilled Senior Lead, Global Compliance and Regulatory Strategy to join our team at Dassault Systèmes. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to mitigate risks.
Key Responsibilities- Engage with regulatory agencies to ensure our 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 goals, business plan, and long-term strategy.
- Grow our Unified Protection Strategy in collaboration with Information Security, Data Privacy, and Cloud Operations.
- Collaborate with 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.
- 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.
- 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.
