Senior Lead, Vertical Integration and Quality Processes, GCS
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.
To proactively engage essential stakeholders within Medidata’s ecosystem, generate value in internal business engagement and create meaningful customer interactions. The seriousness with which Medidata takes its Global Compliance and Strategy function is, we believe, a competitive advantage. We seek the right person to help us maintain and grow that advantage.
Cross functional integration between Global Compliance and Strategy (GCS) organization and other Medidata business functions is a foundational tenet of the GCS strategy. Furthermore, the continued refinement of Medidata’s Quality Management System (QMS) is critical to the ongoing operation of an industry leading QMS. As the Senior Lead, Vertical Integration and Quality Processes, you will collaborate with Medidata internal customer facing business units (Sales, Legal, RFX), grow Medidata’s Unified Protection Strategy in collaboration with Information Security, Data Privacy and Cloud Operations and work closely with the Quality / Customer Management and Regulatory functions within GCS. Reporting to the Senior Director, Vertical Integration / Quality Processes, the position interacts with all levels of management and other personnel within Medidata, as well as with auditors and other Quality and Compliance representatives of Medidata’s clients and prospects. The ideal candidate will be based in Medidata’s Global Headquarters in New York City, though remote candidates will be considered.
Enhance and promote Medidata’s QMS and compliance approach as a Software as a Service (SaaS) technology company providing services to regulated customers. Key audience includes current and prospective customers, customer facing internal departments.
Promotion and adoption of Medidata’s Third Party Assurance and working cross-functionally to ensure control objectives are appropriately designed and operating effectively.
Interfacing with quality and regulatory professionals from clients and prospects
Support of key QMS functional responsibilities including customer audits, customer requests for information, customer relationship management.
Enhance Medidata’s Trust and Transparency resources to further shape the direction of how we support our customers and partners.
Collaborate with GCS peers in the performance and delivery of day-to-day activities of the GCS organization.
Balance multiple priorities workload and complete assignments to ensure the team achieves overall customer focused mission and objectives.
Coordinate with Quality/Customer Management, Regulatory, and Regional teams to incorporate international regulatory developments and considerations within GCS’ delivery to its stakeholders.
Your Education & Experience:
Extensive experience in clinical trial processes and technologies, including a strong working knowledge of Quality Management Systems enablement.
Strong understanding of regulations governing clinical trials including Clinical Regulations (e.g., EU Clinical Trial Directive / Regulation, FDA, etc.) and Framework guidelines including ICH Good Clinical Practices (GCP).
Demonstrated experience as a compliance functional expert (especially with regards to clinical processes and technologies) with proven ability to present to corporate executives.
Inspection management experience is a strong plus.
Ability to travel expected at approximately 10%.
Bachelor's degree or equivalent years of experience; Master’s degree a plus.
Requires a minimum of 10-12 years of experience in Quality Management Systems processes.
Prior experience with a large central IRB or Ethics Committee is preferred.
Prior experience in people leadership is preferred.
Note: The requirements should reflect your minimum requirements for the role in general
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 20,000+ 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 Solutions, Inc. 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, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.