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Senior Global Compliance and Strategy Specialist

2 months ago

New York City, United States Medidata Solutions Full time
Our Industry: Where we play
We sit at the intersection of technology and Life Sciences industries. Humbly, we've been told that we are the leader in application software for the clinical development process, tackling real-world problems and making a real difference in the lives of patients everywhere. With the current transformation in the life sciences industry, we are at the forefront of providing an advanced clinical development platform for our clients to further improve the accuracy, timeliness and ease of the data collection process. That means better treatments can reach waiting patients sooner. We are publicly traded (MDSO) with over 800 customers, customer retention rates above 99%, and the experience of supporting more than 12,000 clinical trials. We are still led by Co-founders, Tarek Sherif and Glen de Vries, and have global operations in US, Europe and Asia.
Mission
The Senior Global Compliance and Strategy 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.
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 backup 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 of experience in life sciences industry and/or medical/clinical operations strongly preferred
Experience with clinical operations preferred
Experience with corrective and preventive action programs
Our Culture: Who we are
We know that creativity doesn't happen on-demand. Developing cutting-edge cloud technology takes great minds and talented people working together in a collaborative environment. That is why we are committed to fostering an innovative, agile company culture. We encourage our teams to come together and experiment with new concepts, research new approaches and test out new technologies. We believe that being part of our team will make a difference in the world.
Our Mission: Powering smarter treatments and healthier people.
Our Vision: To be the most innovative cloud company in Life Sciences.
Our Principles: Integrity, Partnership, Inventiveness, Humility, Nimbleness, Tenacity, Inclusiveness, and Caring.
Our Leadership Drivers:
THINK: Inspires purpose, articulates strategy, and simplifies complexity
TEAM: Communicates effectively, builds relationships and collaborates with others
DO: Plans ahead, scales for growth, ensures accountability
LEARN: Self-aware, values difference, strives to learn
TEACH: Inspires work, coaches others, builds teams
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.
LI-LS
. Apply nowEstimated Salary: $20 to $28 per hour based on qualifications.