Compliance Specialist

Responsibilities

• Regulatory Oversight & Analysis
• Analyze and interpret federal and state pharmacy regulations including but not limited to: CMS, FDA, State Boards of Pharmacy, and DOI.
• Provide consultative assistance related to implementation for operations.
• Maintain awareness of REMS programs and specialty drug compliance requirements.
• Compliance Program Execution
• Coordinate compliance risk assessments for specialty pharmacy functions.
• Support monitoring and auditing work plans.
• Partner with business owners to ensure regulatory requirements are integrated into policies and procedures.
• Coordinate compliance efforts with Pharmacist in Charge.
• Auditing & Monitoring
• Conduct, coordinate and/or review audits of dispensing, documentation, and patient outreach.
• Analyze findings and recommend corrective actions.
• Support external audits including CMS and accreditation reviews.
• Issue Resolution & Risk Mitigation
• Investigate compliance issues and perform risk ranking.
• Develop corrective action plans with stakeholders.
• Track remediation efforts through completion.
• Training & Communication
• Provide information to Corporate Compliance on training including FWA and HIPAA.
• Distribute regulatory updates and communications.
• Work with Pharmacist in Charge to develop training as needed.
• Stakeholder Collaboration
• Advise and/or consult with pharmacy operations and leadership.
• Collaborate with PBMs, manufacturers, and vendors.
• Promote compliance best practices.
• We will adhere to all relevant state and local laws concerning employee leave benefits, in line with our plans and policies.
• Reasonable accommodations

Benefits

Additional Information

The Compliance Specialist II is responsible for supporting the organization's compliance program with a primary focus on specialty pharmacy and patient care regulatory oversight. This role partners with business owners to help ensure adherence to federal and state regulatory requirements, payer contractual obligations, and government required accreditation standards specific to specialty pharmacy services. The Specialist performs regulatory analysis, auditing, monitoring, risk assessments, issue resolution, policy/procedure assistance and compliance education while serving as a subject matter expert for specialty pharmacy-related compliance requirements. We are looking for a Compliance Specialist with: Experience: 4+ years in payer compliance, pharmacy, or clinical operations. Education: Bachelor's degree or equivalent work experience. Preferred Experience Experience with Medicare Part D or pharmacy accreditation preferred. Leadership experience preferred. Certification in healthcare compliance or Pharmacy Tech certification preferred. Licensure as a RN preferred. Core Competencies Regulatory analysis Audit and risk assessment Communication and training Analytical problem solving

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