Director/Senior Director Compliance Monitoring Auditing and Investigations

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Director/Senior Director, Compliance Monitoring, Auditing, and Investigations

The candidate will execute the annual RAMP (Risk Assessment and Mitigation Process) for firm, develop the annual compliance auditing and monitoring strategy, oversee and administer the investigations process, and coordinate the Independent Review Organization with oversight of the Company’s responsibilities under the terms of the Corporate Integrity Agreement. Will conduct annual compliance risk assessment and lead the development of mitigation plans, working with the business to develop and track risk mitigation agreed upon throughout the year. Develop the auditing and monitoring plans, overseeing the execution of these activities and adapting the plan consistent with dynamic business risks as needed. Oversee and administer the investigations process, including management of the hotline and investigations tracker. Conduct monitoring of Sales, Marketing, Medical Affairs, and R&D activities from a corporate compliance perspective; identifying potential areas of vulnerability and risk, and providing guidance on handling and avoiding such situations. Develop and implement corrective action plans in partnership with functional leadership for resolution of problem areas or gaps. Manage live and online auditing and monitoring, including metrics and meaningful reporting for committee meetings. Strategically select auditing and monitoring samples and identify trends and potential risks as necessary. Recognize and respond to compliance issues in a timely manner; following up to resolve and improve processes. Own and continually improve due diligence process, including related government documents and relevant system and cross-functional alignment. Manage all investigations and related processes, collaborating with relevant members of management, legal, HR, and other departments to ensure appropriate outcomes, and serving as a touch-point for investigations committee members. Coordination of the Independent Review Organization (IRO) and oversight of the company’s responsibilities under the terms of the Corporate Integrity Agreement. Supervise, manage, and direct the work of direct report(s) with responsibilities associated with the monitoring, auditing, and investigations function. Perform other duties as assigned.

Additional Information

ref R01674

Company info

United Therapeutics Corporation
1110 Spring Street
Silver Spring
Maryland
United States 20910
Website : http://www.unither.com