The Compliance and Licensing Program Manager is responsible for managing the pharmacy licensing program for both the FPS ambulatory and acute care pharmacy business including federal and state legal and regulatory change monitoring for pharmacy license and practice developments that impact the national FPS business. The Manager extends the Corporate Compliance Program through the adoption and dissemination of established policies and is responsible for leading the FPS Policy and Procedure program and committee. They are also responsible for the development and management of administrative functions and supervision of compliance team members. Additional responsibilities include: manage pharmacist and nurse out-state licensing program, FPS Annual Reporting program, liaison with pharmacy operations to develop policies and procedures necessary for compliance with pharmacy license and practice requirements, represent and advocate FPS interests with boards of pharmacy when variances or other action is necessary, and participate in FHS system compliance.
Responsible for the development and management of administrative functions for the FPS compliance & licensing program and supervision of compliance team members. Mentors and develops compliance team members and fosters a culture of integrity, continuous improvement, efficiency, collaboration and innovation.
Lead the development and execution of FPS compliance activities, consistent with Fairviews overarching compliance program mission, strategy and oversight. Lead FPS compliance, regulatory and licensing committees. Develop policies and procedures for regulatory compliance as ongoing business needs change or new opportunities are explored. Support corporate or other organizational compliance functions and committees, lead and/or participate in FHS system projects as necessary
Manage FPS licensing program including new and renewal pharmacy, out-state pharmacist and nurse licensing, registration, and/or certification with appropriate regulators including state and federal agencies such as the Drug Enforcement Agency as appropriate. Ensure appropriate and timely notifications are made to state and federal regulators regarding changes in FPS pharmacy licensing information;
Monitor legal and regulatory developments and industry best practices for potential impact to any lines of pharmacy business. Advise operations regarding management and mitigation of compliance risks. Assist in the completion of an annual risk assessment.
Serve as an organizational expert resource for interpretations and clarification on state and federal laws and regulations related to drugs and pharmacy. Serve as primary compliance subject matter expert and point of contact to state pharmacy boards and other regulators. Manage all FPS pharmacy variance and policy committee submissions to the Minnesota Board of Pharmacy. Serve as a resource and support for regulatory inspections.
Manage and oversee pharmacy compliance programs related to REMS, DEA ARCOS Reporting, Hazardous Waste, Food Handlers Licensing, Secretary of State and FDA registrations.
Manage the FPS Policy and Procedure Program ensuring timely review and revision of applicable P&Ps and partnering with operations for the necessary training for staff. Provide leadership for the FPS P&P Committee.
Support FPS and serve as a resource to seek or maintain external clinical accreditations, including Utilization Review Accreditation Commission (URAC) and The Joint Commission, specifically for compliance programs
Work collaboratively with stakeholders to ensure seamless service and high levels of communication for ongoing problem solving and troubleshooting
Develop, maintain and submit ongoing pharmacy compliance and inspection reports to identify and monitor trends, gaps and significant compliance issues in accordance with established cadence.
Bachelors Degree in business, health care or related field
5-7 years experience in healthcare compliance, licensing, corporate operations, legal and/or pharmacy operations. Pharmacy compliance, licensure, and regulatory experience are required. Regulatory research, interpretation and analysis skills, and accreditation experience also required.
Completion of masters or advanced degree such as MHA, MBA or JD, with a special focus in healthcare, pharmacy and/or legal and regulatory compliance
Knowledge of HIPAA privacy and security, Fraud, Waste and Abuse, REMS, DEA ARCOS Reporting, Hazardous Waste, Food Handlers Licensing, FDA registrations, URAC and JC accreditation.
Notary Public commission in the State of Minnesota
Healthcare Compliance Professional Certification such as CHC (Certified in Healthcare Compliance)
Certification in Health Privacy Compliance (CHPC); and/or
Admission to the Minnesota Bar Association (JD)
Computer skills including word processing, spreadsheet, and other business software.
Achievement or maintenance of professional certifications.
Interest in and ability to participate in professional development and furtherance activities and cross functional project teams.
Ability to represent Compliance in Board or Audit and Compliance Committee presentations and training .
Together with the University of Minnesota and University of Minnesota Physicians we have created M Health Fairview. M Health Fairview is the newly expanded collaboration among the University of Minnesota, University of Minnesota Physicians, and Fairview Health Services. The healthcare system combines the best of academic and community medicine — expanding access to world-class, breakthrough care through our 10 hospitals and 60 clinics.
Fairview Health Services (fairview.org) is an award-winning, nonprofit health system providing exceptional care across the full spectrum of health care services. Fairview is one of the most comprehensive and geographically accessible systems in the state, with 10 hospitals—including an academic medical center and long-term care hospital—serving the greater Twin Cities metro area.
Its broad continuum also includes 60 primary care clinics, specialty clinics, senior living communities, retail and specialty pharmacies, pharmacy benefit management services, rehabilitation centers, counseling and home health care services, medical transportation, an integrated provider network and health insurer PreferredOne. In partnership ...with the University of Minnesota, Fairview’s 32,000 employees and 2,400 affiliated providers embrace innovation to drive a healthier future through healing, discovery and education.