Manager Compliance and Licensing Program - FPS

Fairview Health Services•Minneapolis, MN

32d

About The Position

The Compliance and Licensing Program Manager is responsible for the development, implementation, and management of 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. This role also includes oversight of the ClearScript, FPS's Pharmacy Benefit Management (PBM), and Integradose (503b compounding pharmacy) compliance and licensing programs The Manager extends the Corporate Compliance Program through the adoption and dissemination of established policies and is responsible for overseeing the Policy and Procedure program(s) and committee(s) for all areas of FPS.. They are also responsible for the development and management/supervision of compliance team members. This role will respond to compliance concerns, investigate when appropriate and partner with operations to implement process improvement initiatives when necessary. They will represent and advocate FPS' interests with boards of pharmacy or other regulatory bodies when variances or other action is necessary. They will participate in FHS system compliance committees.

Requirements

Bachelor's 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.
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.

Nice To Haves

Completion of master's 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)

Responsibilities

Responsible for the development and management of the FPS, ClearScript & Integradose compliance & licensing program and supervision of compliance team members.
Lead the development and execution of FPS, ClearScript & Integradose compliance activities, consistent with Fairview's overarching compliance program mission, strategy and oversight. Oversee the FPS, ClearScript & Integradose 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.
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 assist FPS & ClearScript in the on-going management of the Risk Mitigation Work Plan.
Provide FPS, ClearScript & Integradose business teams with regulatory research, interpretation, and compliance expertise with State and Federal regulations when necessary. Collaborate with legal counsel when necessary.
Serve as a 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.
Oversee the Policy and Procedure Programs at FPS, ClearScript & Integradose, ensuring timely review and revision of applicable P&Ps and partnering with operations for the necessary training for staff.
Manage a compliance oversight program related to formal delegated and downstream entities. Provide oversight and guidance for FPS, ClearScript & Integradose and its downstream entity activities related to external auditing and monitoring. Organize annual delegation audits as necessary for on-going compliance, due diligence and required contractual and operational controls.
Investigate identified compliance matters, including corrective action and mitigation as appropriate. Participate in remediation and corrective action planning for all identified compliance controls and program deficiencies identified by FPS, ClearScript & Integradose for its delegated entities, or by clients for process improvements by FPS, ClearScript or Integradose
Support the maturation of the FPS Compliance Program by identifying and implementing process improvements, as well as identifying and implementing new processes for cross functional improvement and added value.