Job Description

About our Company

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Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million users trust Medidata's seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. Discover more at www.medidata.com.

About the Team

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Medidata is the industry leader in clinical trial technology, accelerating life-saving medicines to patients globally. Our technologies operate within one of the world's most highly regulated sectors, safeguarding

quality management, patient safety, data security, and privacy

. The Global Compliance and Strategy (GCS) department is a leading, cutting-edge function responsible for proactively driving innovation while ensuring continuous global regulatory compliance.


The GCS team delivers meaningful value to both internal and external stakeholders (e.g., Sales, Product, R&D, and Customers) by applying a risk-based approach to continuously improving quality and regulatory excellence across the global landscape.

Responsibilities

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With Medidata's continued growth in the Asia regions (including Japan, China, Korea, Singapore, and Australia), the ideal candidate will serve as a regional GCS resource and will work with the global GCS team to serve its stakeholders.

Direct Customer & Partner Interaction:

Lead interactions with regional customers to proactively address and resolve complex quality and regulatory matters relevant to the use of technology in performing clinical trials.

Operational Excellence & Auditing:

Fulfill core responsibilities for providing operational support to GCS-managed programs, including: + Directly supporting customer audits/inspections.
+ Managing the quality incident process.
+ Performing internal quality system audits.

Drive Technology Adoption & Compliance:

Serve as a key GCS resource within the APAC region, enabling 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 requirements.

Regional Regulatory Engagement:

Proactively engage with key regulatory agencies within China and across the APAC region (including Japan, Korea, Singapore, and Australia) to ensure our platform and services align with established and emerging expectations.

Cross-Functional Collaboration:

Collaborate effectively with peer GCS team members and other Medidata business units (e.g., Legal, IT, Product, Sales) to contribute to achieving Medidata's regional and long-term strategic goals.

Travel:

Ability to travel expected at approximately 10% within the region.

Qualifications

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Required Languages:

Fluency (written and spoken) in English and Mandarin is required, enabling effective

regional client support and regulatory engagement

. Fluency in Korean or Japanese is strongly preferred and highly advantageous.

Regulatory Expertise:

Strong, demonstrated understanding of local and global clinical trial regulations (e.g., NMPA, EU CTR, FDA) and framework guidelines, including ICH Good Clinical Practice (GCP), used to guide and advise customers on technology adoption.

QMS Experience:

Deep understanding of quality systems processes, including auditing, root cause analysis, and CAPA development, applied directly to

support customer quality excellence and incident resolution

.

Clinical Technology Experience:

Extensive experience with modern clinical trial processes and technologies (e.g., eTMF, decentralized trials, EDC) necessary to

expertly advise customers on compliant usage and new solution adoption.

Inspection & Audit Management:

Experience with

supporting and managing customer audits/inspections

is strongly preferred.

Autonomy & Problem Solving:

Proven track record of working independently to evaluate complex regulatory requirements and propose

effective, customer-focused, compliant solutions.

Manage Priorities:

Expertly balance and manage competing

customer-facing

priorities and workloads to ensure the GCS team achieves its mission.

Communication & Teamwork:

Exceptional collaboration and communication skills, with the ability to articulate complex regulatory issues

clearly and persuasively to customers and senior executives.

Thought Leadership:

the ability to present at external forums on topics related to clinical trial technologies and compliance.

Education:

Bachelor's degree required. A Master's degree is preferred.

Industry Experience:

A minimum of 15 years of experience in the Life Sciences industry and/or medical/clinical operations (or 12 years with a Master's degree). GxP experience is a significant plus.

QMS Experience:

A minimum of 5 years of experience focused on Quality Management Systems processes.

Clinical Technology Focus:

A minimum of 2 to 3 years of experience with clinical trial processes and technologies.

Compliance Leadership:

Demonstrated experience as a

compliance functional expert

(especially related to clinical processes and technologies) with a proven ability to present to senior corporate executives.

Location:

This role is based out of Medidata's Singapore office.


Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, life and disability insurance; paid time off; paid sick leave; Employee Assistance Program; and paid parental leaves.

Applications will be accepted on an ongoing basis until the position is filled.


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Inclusion statement

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As a game-changer in sustainable technology and innovation, Dassault Systemes 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.