Director Of Regulatory Policy

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Director Of Regulatory Policy
Duties: Identifying and assessing regulatory and compliance risks that affect the School. Developing and implementing work plans to address regulatory and compliance risks, and provide regular status reports in close collaboration with School officials, Medicine Compliance, and other compliance offices. Overseeing implementation of compliance policies and procedures across the School of Medicine. Acting as primary point of contact for the School in receiving inquiries and/or reported regulatory concerns, making appropriate referrals, coordinating/directing investigations, developing and implementing administrative responses to findings of noncompliance. Creating and implementing effective strategies to monitor the School’s compliance with compliance policies and regulatory and training requirements. Works closely with the School of Medicine, Medicine Compliance and offices in developing program goals and policies and implementing/overseeing processes. Working as needed with the School, Medicine Compliance, and offices, develop and implement policies and procedures related to the School’s standards of conduct and compliance with applicable laws and regulations, particularly those pertaining to research including research involving humans and animals, safety, healthcare billing and reimbursement, prevention of fraud and abuse, health care privacy, confidentiality, and security, finance and business including Stark and Anti-Kickback, academic, international and other identified areas. Oversee, direct and conduct internal reviews to assess School compliance with applicable laws and regulations. Conduct, supervise, coordinate, or support investigations of alleged compliance violations; collaborate and coordinate with School officials and managers to ensure remediation of confirmed non-compliance or potential problems. Develop and implement, individually and in collaboration with others, effective compliance-related training and educational programs for SCHOOL faculty and staff; manage compliance with training required and/or provided by others. Under the general direction of the Director of External Business Relations, develop periodic compliance reports to Medicine senior leadership, and present reports to Medicine Compliance and Medicine Board committees as appropriate. Provide leadership in overseeing reporting system for employees to report concerns and obtain assistance; ensure adequate mechanisms exist .for enforcement of compliance requirements and appropriate disciplinary action in instances of violation of those requirements; serve as referral source and coordination point for and between faculty , staff, students and trainees, departments and School officials, Medicine Compliance, and upper campus offices in addressing and answering compliance related complaints. Develop and manage SCHOOL regulatory and compliance resources that are accessible on-line, and coordinate with Medicine Compliance regarding content and links to its website. Coordinate closely with legal counsel, compliance personnel designated by specific School departments, and compliance committees established by the School or specific departments; serve as a member of School, Medicine and compliance-related committees as appropriate. Advise on operational and policy decisions and institutional initiatives that will enhance SCHOOL’s programs and their management and administration, and report to the Director of External Business Relations on issues of concern regarding SCHOOL’s compliance with federal and state regulations. Foster close working relationships with School staff, including Business Unit directors, to address regulatory and compliance issues of mutual concern such as those related to personnel or scientific misconduct matters. Ensure adequate records are maintained to document compliance efforts and corrective actions. Collaborate with Medicine Compliance to assure overall coordination of Medicine Compliance policies, programs, and projects. Serve as the School privacy liaison, working closely with the Medicine Chief Privacy Officer, to ensure compliance with federal and state requirements related to privacy and information security, actively participate in the management of shared issues and the handling of cross entity incident. Communicate, or facilitate communications, with regulatory agencies regarding investigations and alleged violation resolutions. Develop and conduct regulatory training, e.g., orientations and department and unit meetings. Conduct or participate in conducting risk assessments for targeted compliance focus by the School. As requested, provide support to the Director of Regulatory Guidance regarding the review of outside work requests and conflict of interest issues. As requested, participate in negotiating, reviewing, and finalizing goods and services agreements. As requested, serve as the School point of contact for the review of data use agreements, non-disclosure agreements, and other miscellaneous agreements involving the School and its departments or faculty. Along with the Director of Regulatory Guidance, service as a primary School point of contact for conflict of interest and ethics issues. Conduct or participate in personnel related investigations that involve allegations of non-compliance or failure to follow regulations or policies.

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