Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial & real-world data. Powered by artificial intelligence & delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies & academic researchers accelerate value, minimize risk & optimize outcomes. Medidata serves more than 1,000 customers & partners worldwide & 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 & are fully committed to selecting leaders & employees that represent the markets in which we operate. We are still led by our Co-founders, Tarek Sherif & Glen de Vries, & have global operations in US, Europe & Asia with over 2000 employees.
The Sr. Quality Assurance & Regulatory Affairs Specialist is responsible for performing business-related operations of the Global Compliance & Strategy (GCS) department, including but not limited to providing backup support for client audits & providing operational support to GCS-managed programs, as applicable. The position interacts with all levels of management & other personnel within Medidata, as well as with auditors & other representatives of Medidata’s clients & prospects.
- 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, & following-up on client audits of Medidata
- Coordination of audit responses & the preparation & delivery of Medidata’s audit response to external auditors
- Assist GCS management with activities related to client regulatory inspections & internal audits; & regulatory inspections of Medidata itself
- Fulfill requests from other departments within Medidata related to quality & regulatory information & 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 & verbal/written communication skills
- Knowledge of life sciences regulatory requirements preferred
- Knowledge of Quality Management systems
Your Education & 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 & preventive action programs
Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug & medical device development, enabling life-saving drugs & medical devices to get to market faster. Our products sit at the convergence of the Technology & 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 & intelligent data analytics, bringing an unmatched level of quality & efficiency to clinical trials enabling treatments to reach waiting patients sooner.
Medidata Solutions is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees & 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 & local laws governing non-discrimination in employment in every location in which the company has facilities.