北京招聘

Your Mission

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 company’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 company’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 company’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 company business units (e.g. Legal, Information Technology, Product Development) to contribute to achieving company’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).

Your Competencies

· 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.

company 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 platform.

多年来一直专注于于为世界500强，跨国公司，国内上市公司提供管理咨询，人力资源咨询和中高端招聘服务，为中高级职业经理人提供更好的职业发展机会。
在中国服务力量遍布在北京、上海、广州、深圳、成都、南京、宁波、苏州等多个城市, 超过100名专业咨询顾问。