Director, Global Compliance and Strategy APAC

With Medidata’s continued growth in the Asia regions (including Japan, China, Korea, Singapore, and Australia), the ideal candidate will serve as a geographically local resource focusing on matters related to Medidata’s Quality Management System and regulatory strategy.

Reporting directly to the SVP, Global Compliance and Strategy (“GCS”), the ideal candidate will:

• Engage with key local regulatory agencies (e.g. PMDA (Japan), NMPA (China), , MFDS (Korea), HSA (Singapore)) and government authorities (e.g. China HGRAC) to ensure that Medidata’s interest as a Software as a Service (SaaS) technology company serving regulated companies is 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 cross-functionally with other Medidata business units (e.g. Legal, Information Technology, Product Development) to contribute to achieving Medidata’s goals, business plan, and long-term strategy.
• Supervise team resources located within the Asia region.

The ideal candidate will also have responsibilities for providing operational support to GCS-managed programs (e.g. quality incident management, internal quality system audits, customer audit needs).

• Strong understanding of regulations governing clinical trials, including:
• • Framework guidelines including ICH Good Clinical Practices (GCP) and regional distinctions.
  • Clinical Regulations (e.g. Human Genetic Resource Management Regulation, CFDA Technical Guidelines on Accepting Overseas Clinical Trial Data of Medical Devices, and etc.).
  • Regulations on data management in clinical trials
  • Computer Systems Validation
• Extensive experience in clinical trial processes and technologies, including, but not limited to a strong working knowledge of trial master file and site master files (TMF/SMF) and eTMF.
• Demonstrated experience as a compliance functional expert (especially with regards to clinical processes and technologies) with proven ability to present to senior executives.
• Quality systems processes and enablement including auditing.
• Data privacy and security requirements under China Cybersecurity Law(s).
• Inspection management experience.
• Proven track record of working independently to evaluate requirements and propose solutions
• Fluent (read, write, speak) in Mandarin and English
• Residing in Singapore - able to be present in the local office 3x days/week
• Able to travel within the region.

Inclusion statement

As a game-changer in sustainable technology and innovation, Dassault Systèmes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future.