(PRC-Beijing/Shanghai) Senior Lead Global Compliance and Strategy, APeJ
Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial and real-world data. Powered by artificial intelligence and delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.mdsol.com
We know that diverse teams win and are fully committed to selecting leaders and employees that represent the markets in which we operate. We are still led by our Co-founders, Tarek Sherif and Glen de Vries, and have global operations in US, Europe and Asia with over 2000 employees.
Enable both internal and external stakeholders to progressively enhance Medidata’s value proposition through the adoption of emerging clinical trial technologies while successfully navigating local and global regulatory expectations. With Medidata’s continued growth in the Asia markets of China, Korea, and Singapore (“APeJ”), 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. CNDA, CDE, MFDS (Korea), HSA (Singapore)) and government authorities (e.g. 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.
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 China distinctions.
Clinical Regulations (e.g. Notice on the Implementation of Administrative License for the Collection, Collection, Sale, Export, and Exit of Human Genetic Resources, CFDA Technical Guidelines on Accepting Overseas Clinical Trial Data of Medical Devices, and etc).
Regulations on data management in clinical trials (e.g. the CFDA Technical Guide on Clinical Trial Data Management)
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 Beijing (preferable) or 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’s solutions have powered over 14,000 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.