Senior Lead, Global Compliance and Regulatory Strategy
il y a 4 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.
-
Senior Lead, Global Compliance and Strategy
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinAbout Our Company:At Dassault Systèmes, we empower our clients to create innovative solutions that transform industries and improve lives.About the Role:We are seeking a highly skilled Senior Lead, Global Compliance and Strategy to join our team in Japan. As a key member of our Global Compliance and Strategy team, you will play a critical role in ensuring...
-
Senior Lead, Global Regulatory Compliance Officer
il y a 2 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinAbout the RoleWe are seeking a highly experienced Senior Lead, Global Regulatory Compliance Officer to join our team at Medidata. The successful candidate will be responsible for ensuring our company's Quality Management System and regulatory strategy are aligned with global regulatory expectations.Key Responsibilities:Engage with local regulatory agencies...
-
Senior Lead, Global Compliance and Strategy
il y a 3 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinAbout Our CompanyAt Dassault Systèmes, we are committed to empowering smarter treatments and healthier people. As a global leader in the life sciences industry, we offer innovative solutions to address the complex challenges of clinical trials.About the TeamThe Asia region, including Japan, China, Korea, Singapore, and Australia, is a key focus area for our...
-
Senior License Compliance Investigator
il y a 1 mois
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinSenior License Compliance InvestigatorRole OverviewAs a Senior License Compliance Investigator at Dassault Systèmes, you will be responsible for managing and leading customer engagements to protect our intellectual property and revenue while maintaining strong relationships with our clients.Key ResponsibilitiesManage and lead customer engagements to resolve...
-
Senior Quality and Customer Management Specialist
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinJob SummaryWe are seeking a highly skilled Senior Specialist, Quality and Customer Management to join our Global Compliance and Strategy team at Dassault Systèmes. The successful candidate will be responsible for performing business-related operations of the GCS department, including document management, quality incident management, and regulatory...
-
Software Compliance Specialist
il y a 3 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinUnlock your potential with Dassault Systèmes, a global leader in Scientific Software Engineering as a License Compliance Investigator in ChinaAt Dassault Systèmes, we empower people with passion to change the world. Let's open new horizons together with the power of 3DEXPERIENCE virtual universes Key ResponsibilitiesDevelop and maintain the supporting...
-
Senior Quality and Customer Management Specialist
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinJob Summary:We are seeking a highly skilled Senior Specialist, Quality and Customer Management to join our Global Compliance and Strategy team at Dassault Systèmes. This role will be responsible for performing business-related operations, including document management, quality incident management, and audit coordination.Key Responsibilities:Provide support...
-
License Compliance Investigator
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinUnlock your potential with Dassault Systèmes, a global leader in Scientific Software Engineering as a License Compliance Investigator in ChinaAt Dassault Systèmes, we empower people with passion to change the world. Let's open new horizons together with the power of 3DEXPERIENCE virtual universes Key ResponsibilitiesDevelop and maintain the supporting...
-
Dassault Systèmes Compliance Investigator
il y a 2 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinReveal new opportunities with Dassault Systèmes, a pioneering leader in Scientific Software Engineering as a Compliance InvestigatorAt Dassault Systèmes, we empower visionaries to change the world. Let's explore new horizons together with the power of 3DEXPERIENCE virtual universesJob Role & ResponsibilitiesSupport the Manager in developing the supporting...
-
Software Compliance Specialist
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinCompliance Engineer for IT InfrastructureDassault Systèmes is seeking a motivated Compliance Engineer to spearhead the SCCM, Forescout, and EDR domain in our APAC IT organization.This role will teach and help grow project management skills along with technical abilities, ability to work autonomously and learn new technologies and make changes to process and...
-
Senior Quality and Customer Management Specialist
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinJob SummaryWe are seeking a highly skilled Senior Specialist, Quality and Customer Management to join our Global Compliance and Strategy team at Dassault Systèmes. The successful candidate will be responsible for performing business-related operations of the GCS department, including document management, quality incident management, and audit support.Key...
-
Software Compliance Expert
il y a 4 jours
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinUnlock Your Potential with Dassault SystèmesWe are seeking a highly skilled and experienced License Compliance Senior Investigator to join our team in Gurgaon, India.Job Description:The successful candidate will be responsible for managing customer engagements, working closely with the LC team and Channel teams to achieve program objectives. They will also...
-
Software Compliance Specialist
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinCompliance Engineer for IT InfrastructureDassault Systèmes is seeking a motivated Compliance Engineer to spearhead the SCCM, Forescout (SNA) and EDR domain in our APAC IT organization.This role will teach and help grow project management skills along with technical abilities, ability to work autonomously and learn new technologies and make changes to...
-
License Compliance Investigator
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinUnlock your potential with Dassault Systèmes, a global leader in Scientific Software Engineering as a License Compliance Investigator in ChinaAt Dassault Systèmes, we empower people with passion to change the world. Let's open new horizons together with the power of 3DEXPERIENCE virtual universes Key ResponsibilitiesDevelop and maintain the supporting...
-
Tax Compliance Specialist
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinJob SummaryWe are seeking a highly skilled Tax Compliance Specialist to join our team at Dassault Systèmes. As a Tax Compliance Specialist, you will be responsible for coordinating and managing tax compliance tasks for Asia legal entities, ensuring accurate and timely submission as required by tax regulations and tax authorities.Key ResponsibilitiesLead...
-
Data Architect
il y a 1 mois
Vélizy-Villacoublay, Île-de-France Safran Temps pleinJob SummaryAs a Data Architect at Safran, you will play a key role in designing and implementing the company's data architecture and strategy. This is a unique opportunity to contribute to the digital transformation of a global high-tech group, operating in the aviation, defense, and space markets.Key Responsibilities: Design and implement data architecture...
-
China Intellectual Property Compliance Specialist
il y a 2 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinDS Software Intellectual Property ProtectionJob Description: To resolve infringement of DS software intellectual property (IP) with Investigator engagement with infringers/customers. To create and drive strategies for the DS anti-piracy and compliance program. Strategies include the identification of infringements of software IP via innovative and constantly...
-
Senior Counsel
il y a 1 semaine
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinAbout our organization:Dassault Systèmes: A leader in the life sciences and technology industry.We are seeking a highly skilled Senior Data Privacy Counsel to join our team. The successful candidate will be responsible for providing expert advice on data privacy matters, ensuring compliance with relevant laws and regulations.Key responsibilities...
-
Software Compliance Specialist
il y a 2 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinJob SummaryWe are seeking a highly motivated Compliance Engineer to spearhead our SCCM, Forescout (SNA) and EDR domain in the APAC IT organization. This role will involve technical leadership, project management, and process improvement to enhance the security of IT endpoint devices and servers.The ideal candidate will have 6-7 years of experience in...
-
Senior Channel Sales Manager Italy
il y a 4 semaines
Vélizy-Villacoublay, Île-de-France Dassault Systèmes Temps pleinDassault Systèmes is seeking a sales-driven and results-oriented Senior Channel Sales Manager to join our team based in Italy. The ideal candidate will be responsible for leading and growing our key top clients alongside our partners, ensuring the successful adoption of our solutions within the Italian market.Key Responsibilities:Be the Partner Trusted...