Regulatory Compliance Coordinator

Pharmacy Compliance Coordinator Full Time Coraopolis, PA, US 10 days ago Requisition ID: 1598 Purpose The Pharmacy Compliance Coordinator is responsible for developing, implementing, and maintaining a comprehensive compliance program for the pharmacy. This role ensures adherence to all applicable federal and state laws, regulations, and accreditation standards, as well as internal policies and procedures. The Coordinator will work closely with pharmacy staff, management, and other stakeholders to promote a culture of compliance and ethical conduct. Responsibilities Monitor and ensure compliance with applicable regulations and accreditation standards: Continuously monitor federal and state pharmacy regulations, accreditation standards (e.g., URAC, ACHC, PCAB), and other relevant legal requirements. Analyze the impact of new and changing regulations and communicate updates to relevant personnel. Develop and maintain policies & procedures: Develop, implement, and revise written policies and procedures that address all applicable regulatory requirements and industry best practices. Ensure these documents are readily accessible and understood by pharmacy staff. Manage compliance training: Design and deliver training programs for pharmacy staff on compliance-related topics, including but not limited to HIPAA, controlled substances handling, fraud and abuse prevention, and state-specific regulations. Maintain training records and ensure compliance with mandatory training requirements. Support internal and external auditing: Conduct regular audits and monitoring activities to assess compliance with policies, procedures, and regulations. Identify potential compliance gaps and develop corrective action plans to address them. Serve as the primary point of contact for any third-party audits. Document all audit findings and remediation efforts, including CAPAs. Manage incident response policy and support in any incidents: Establish and manage a system for reporting, investigating, and resolving compliance incidents. Serve as a primary point of contact and scribe during incidents, tracking all key moments in an incident for future analysis. Conduct thorough investigations, document findings, and implement corrective actions to prevent recurrence. Report incidents to appropriate regulatory agencies as required. Manage licensing, credentialing, and accreditation as necessary for facilities and individuals: Maintain oversight of pharmacy licenses, permits, and pharmacist/technician credentials. Ensure timely renewals and compliance with all licensing requirements. Work with pharmacy staff to support accreditation efforts and maintenance. Support contract management: Work with the contracting team to review contracts with third-party payers and manufacturers. Ensure all contracts with vendors and other entities comply with internal policies and procedures, as well as relevant regulations and contractual obligations. Serve as compliance liaison to leadership: Work with leaders to support and contribute to the strategic direction of Vanscoy Rare Pharmacy’s compliance team and efforts. Communicate and collaborate: Effectively communicate compliance-related information to pharmacy staff, management, and other stakeholders. Collaborate with other departments (e.g., legal, risk management) to address compliance issues. Manage compliance reporting: Prepare and submit regular reports on compliance activities, including audit findings, incident reports, and training completion rates. Stay current on relevant topics: Maintain current knowledge of pharmacy regulations, industry best practices, and compliance trends. Participate in professional development activities to enhance expertise. Support company culture: Work with team members in a fashion that is in line with Vanscoy Rare Pharmacy’s values. Support special projects: Participate in special projects related to compliance, such as implementing new technologies or preparing for accreditation surveys. Serve as a relevant “Officer” as requested: Based on future needs, the Compliance Coordinator may be asked to serve as a Compliance Officer, Privacy Officer, Safety Officer, and/or Security Officer as deemed appropriate by leadership. Required Qualifications Bachelor's Degree in Healthcare Administration , or a related field preferred . R elevant experience may be substituted for a degree. Minimum of 3 years of experience in pharmacy operations, compliance, or a related field. Thorough understanding of federal and state pharmacy laws and regulations (e.g., HIPAA, Controlled Substances Act, Stark Law, Anti-Kickback Statute). Experience with accreditation standards (e.g., URAC, ACHC, PCAB). Strong analytical, problem-solving, and communication skills. Ability to work independently and as part of a team. Detail-oriented and organized, with the ability to manage multiple projects simultaneously. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Preferred Qualifications Experience in a hospital, retail, or specialty pharmacy setting. Knowledge of pharmacy information systems and technology. Certification in Healthcare Compliance (CHC) or similar certification is preferred. Knowledge of Rare Pharmacy accreditation standards Work Environment This job operates in a professional office environment and teleworking from the employee’s home address listed in their employment file. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. When telecommuting employees must have reliable internet access in order to access required systems and software associated with the position's responsibilities. The amount of time the employee is expected to work per day or pay period will not change as a result of participation in the teleworking program. Employees are responsible for the set-up of their home office environment, including physical set-up, internet connection, phone line, electricity, good lighting, comfortable temperature, furniture, etc. Employee’s teleworking space should be separate and distinct from their “home space” and allow for privacy. Vanscoy Rare Pharmacy expects employees teleworking to be as efficient and professional as if they were in the office. The amount of time spent in office or teleworking is contingent upon the needs/priorities of Vanscoy Rare Pharmacy and will vary based on those needs/priorities. Physical Demands While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands and fingers, handle or feel; and reach with hands and arms. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of the job. #J-18808-Ljbffr