Medidata Solutions, Inc. Sr. Quality Assurance & Regulatory Affairs Specialist in New York, New York

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.

Your Mission:

The Sr. Quality Assurance & Regulatory Affairs Specialist is responsible for performing business-related operations of the Global Compliance and Strategy (GCS) department, including but not limited to providing backup support for client audits and providing operational support to GCS-managed programs, as applicable. The position interacts with all levels of management and other personnel within Medidata, as well as with auditors and other representatives of Medidata’s clients and prospects.

Your Competencies:

  • Provide operational support to GCS-managed programs, including:

  • Quality Incident (QI) management

  • Exception/Pilot program

  • Supplier evaluation/audit

  • Quality System Document management

  • Internal Quality System audit (in coordination with department-led operational self assessments)

  • Provide operational support for client audits, including:

  • Scheduling, preparing for, hosting, and following-up on client audits of Medidata

  • Coordination of audit responses and the preparation and delivery of Medidata’s audit response to external auditors

  • Assist GCS management with activities related to client regulatory inspections and internal audits; and regulatory inspections of Medidata itself

  • Fulfill requests from other departments within Medidata related to quality and regulatory information and documentation for clients

  • Fulfill requests from GCS management related to the department’s business operations (e.g., metrics, status updates)

  • Moderate to expert knowledge of Microsoft Office suite

  • Effective interpersonal and verbal/written communication skills

  • Knowledge of life sciences regulatory requirements preferred

  • Knowledge of Quality Management systems

Your Education and Experience:

  • College degree (Bachelors) or higher) strongly preferred

  • 2+ years hosting/conducting audits and/or quality system experience preferred

  • 2+ years experience in life sciences industry and/or medical/clinical operations strongly preferred

  • Experience with clinical operations preferred

  • Experience with corrective and preventive action programs

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.

EEO Statement

US:

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.

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