Director, Global Compliance and Strategy, APAC
Medidata: Conquering Diseases Together
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,400 customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com.
Medidata Global Compliance and Strategy’s (GCS) missions is to help its stakeholders successfully navigate and interpret the global regulatory landscape thereby enabling Medidata’s clients to maximize the potential of the Medidata Cloud unified platform. The GCS team creates meaningful customer interactions through the application of a risk-based approach to continuously improving quality within the global regulatory landscape.
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 VP, 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 Shanghai; able to travel within the region.
Your Education & Experience:
Bachelor's degree required with 12 years of experience, 8 years experience with a Master’s; or equivalent years of experience in the life sciences industry and/or medical/clinical operations.
Requires a minimum of 3 to 5 years of experience in clinical development quality assurance.
Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform.
Medidata Solutions have powered over 17,000+ clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.
Medidata Information Technology (Shanghai) Co., Ltd.is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability or other factors that are unrelated to the legitimate business interests of Medidata Solutions.