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Senior Lead, Global Compliance and Regulatory Strategy
Il y a 2 mois
About Our Company
Dassault Systèmes: Empowering Innovation and Excellence
About the Team
We are a leading global company in the life sciences industry, and we are seeking a highly skilled and experienced professional to join our team as a Senior Lead, Global Compliance and Regulatory Strategy. As a key member of our organization, you will play a critical role in ensuring that our company remains compliant with all relevant regulations and guidelines.
- You will engage with local regulatory agencies and government authorities to ensure that our company's interests are represented in regulatory guidance documents and agency perceptions.
- You will interact directly with customers to address quality and regulatory-related matters relevant to the use of technology in performing clinical trials.
- You will collaborate with other departments, including Legal, Information Technology, Product Development, Sales, and RFX, to help achieve our company's goals and business plan.
- You will grow our Unified Protection Strategy in collaboration with Information Security, Data Privacy, and Cloud Operations, and work with the Quality/Customer Management and Regulatory functions within our organization.
- You will collaborate with peers in the performance and delivery of daily activities of our organization.
- You will balance project priorities, workload, and complete assignments to ensure that our team achieves overall customer-focused mission and objectives.
- You will fulfill the responsibilities for providing operational support to our organization-managed programs, including quality incident management, internal quality system audits, customer audit/inspection needs.
Responsibilities
You will have a strong understanding of regulations governing clinical trials, including:
- Framework guidelines, including 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.
- Understanding of quality systems processes and enablement, including auditing, root cause analysis, and CAPA development.
- PMDA inspection experience is preferred.
Qualifications
You will require:
- A Bachelor's degree with 8 years of experience, or 5 years of experience with a Master's degree; or equivalent years of experience in the life sciences industry and/or medical/clinical operations.
- 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.
- A 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 a proven ability to present to corporate executives.
- Inspection management experience is a strong plus.
- Ability to travel expected at approximately 10%.
What We Offer
We offer a comprehensive compensation package, including a competitive base salary, commission on sales positions, and annual bonuses for non-sales positions. We also provide best-in-class benefits, including medical, life, and disability insurance, paid time off, paid sick leave, Employee Assistance Program, and paid parental leaves.
