Senior Lead, Global Compliance and Strategy, APAC (治験業務経験者)

Your Mission:

With Medidata’s continued growth in the Asia regions (including Japan, China, Korea, Singapore, and Australia), the ideal candidate will serve aクイーン カジノ 登録 geographically local resource focusing on matters related to Medidata’s Quality Management System and regulatory strategy with a specific focus on the Japan market and region. Enable both internal and external stakeholders to progressively enhance Medidata’s value proposition through the adoption of emerging clinical trial technologies while successfully meeting and navigating global regulatory expectations. Reporting directly to the Director, Global Compliance and Strategy (“GCS”) APAC, the ideal candidate will:

• Engage with key local regulatory agencies in the Japan region (e.g. PMDA, JPMA) and government authorities if applicable to ensure that Medidata’s interest aクイーン カジノ 登録 Software aクイーン カジノ 登録 Service (SaaS) technology company serving regulated companies is considered in regulatory guidance documentクイーン カジノ 登録nd 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, Sales, RFX) to contribute to achieving Medidata’s goals, business plan, and long-term strategy.
• Grow Medidata’s Unified Protection Strategy in collaboration with Information Security, Data Privacy and Cloud Operationクイーン カジノ 登録nd work closely with the Quality/Customer Management and Regulatory functions within GCS.
• Collaborate with GCS peers in the performance and delivery of day-to-day activities of the GCS organization.
• Balance multiple priorities, workload, クイーン カジノ 登録omplete assignments to ensure the team achieves overall customer focused mission and objectives.
• Fulfill the responsibilities for providing operational support to GCS-managed programs (e.g. quality incident management, internal quality system audits, customer audit/inspection needs).

クイーン カジノ 登録ompetencies:

• Strong understanding of regulations governing clinical trials, including:
• Framework guidelines including ICH Good Clinical Practices (GCP) and regional distinctions.
• Clinical Regulations (e.g. JGCP, specific requirements in Japan on Clinical trials, and PMDA inspections).
• Regulations on data management in clinical trials.
• Computer Systems Validation.
• Extensive experience in clinical trial processeクイーン カジノ 登録nd technologies, including, but not limited to a strong working knowledge of trial master file and site master files (TMF/SMF) and eTMF.
• Understands quality systems processeクイーン カジノ 登録nd enablement including auditing, root cause analysiクイーン カジノ 登録nd CAPA development.
• PMDA inspection experience is preferred.
• Proven track record of working independently to evaluate requirementクイーン カジノ 登録nd propose solutions.
• Strong teamwork spirit and good communication skills.
• Fluent (read, write, speak) in English and Japanese.
• Based in Medidata’s Tokyo office.

Your Education & Experience:

• 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.
• Requireクイーン カジノ 登録 minimum of 2 to 3 years of experience in clinical trial processeクイーン カジノ 登録nd technologies, including a strong working knowledge of Quality Management Systems enablement.
• Strong understanding of regulations governing clinical trials including Clinical Regulationクイーン カジノ 登録nd Framework guidelines including ICH Good Clinical Practices (GCP).
• Demonstrated experience aクイーン カジノ 登録 compliance functional expert (especially with regards to clinical processeクイーン カジノ 登録nd technologies) with proven ability to present to corporate executives.
• Inspection management experience iクイーン カジノ 登録 strong plus.
• Ability to travel expected at approximately 10%.
• Able to work independently.
• Prior experience with a large central IRB or Ethics Committee is preferred.