Senior Specialist, Quality and Customer Management

United States, NY, New York
Regular
7/10/2024
539850

Location: Hybrid

Medidata follows a hybrid office policy in which employees who are hired for an in-person position are expected to work on site a certain number of days per week following Company policy.

About our Company:

Medidata: Powering Smarter Treatments and Healthier People

Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences, creating hope for millions of people. 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 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Known for its groundbreaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. Medidata 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 and follow us on LinkedIn, Instagram, and X.

About the Team:

Medidata Global Compliance and Strategy's (GCS) mission is to help its stakeholders navigate and interpret the global regulatory landscape thereby allowing Medidata's clients to maximize the potential of the Medidata Cloud unified platform. The GCS team creates meaningful customer interactions through a risk-based approach to improving quality within the global regulatory landscape.

Responsibilities:

The Senior Specialist, Quality and Customer Management, performs business-related operations of the Global Compliance and Strategy (GCS) department. Primary job responsibilities include:

  • Document a quality management system, providing backup support for client audits and providing operational support to GCS-managed programs, as applicable.
  • You will work with all levels of management and other personnel within Medidata, and with auditors and other representatives of Medidata's clients and prospects.

The Senior Specialist, Quality and Customer Management performs business-related operations of the Global Compliance and Strategy (GCS) department, including:

  • Provide support for client audits and providing operational support to GCS-managed programs, as applicable.
  • You will work with all levels of management and other personnel within Medidata, and with auditors and other representatives of Medidata's clients and prospects
  • Experience in the design and implementation, and practical experience related to life sciences regulatory landscape and associated Quality Management Systems.
  • Promotion and adoption of Medidata's Third-party Assurance and working to ensure control objectives are designed and operating effectively.
  • Provide support for client audits, including: scheduling, preparing for, hosting, and following-up on client audits of Medidata
  • Coordinate audit responses and the preparation and delivery of Medidata's audit response to external auditors
  • 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 ( with department-led operational self assessments)
  • Assist GCS management with activities related to client regulatory inspections and internal audits; and regulatory inspections of Medidata itself
  • Respond to 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)

Qualifications:

  • A minimum of a College degree (Bachelors) is required
  • Requires ~3 years experience in clinical trial processes and technologies, including a strong working knowledge of Quality Management Systems enablement, ideally in the area of quality system audits
  • Experience with corrective and preventive action programs
  • Experience with clinical operations

The salary range posted below refers only to positions that will be physically based in New York City. As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. Pay ranges for candidates in locations other than New York City, may differ based on the local market data in that region. The base salary pay range for this position is $78,900 - $106,000.

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, dental, life and disability insurance; 401(k) matching; flexible paid time off; and 10 paid holidays per year.

Equal Employment Opportunity:

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age, disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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

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Diversity statement

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

Equal opportunity

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at 3DS are based on merit, qualifications and abilities. 3DS is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age (40 and above), disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. 3DS will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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MEDIDATA generates the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes.