Regulatory & Compliance Analyst Job

Regulatory & Compliance Analyst is needed to perform the following duties :

• Monitor daily pharmacy operations to ensure compliance with applicable federal and state laws, Board of Pharmacy rules, HIPAA privacy requirements, and internal compliance policies and procedures.
• Review prescription-processing workflows, patient-profile documentation, refill records, and dispensing-related entries in PrimeRx to identify compliance gaps, documentation deficiencies, and operational risks.
• Review and maintain controlled-substance records, perpetual inventory logs, invoices, storage documentation, discrepancy reports, and related Schedule II–V compliance records for accuracy and inspection readiness.
• Conduct internal compliance reviews and support audit preparation by examining pharmacy records, documentation logs, claim-support files, refrigerator logs, and other regulatory records, while tracking corrective and preventive actions.
• Draft, revise, and maintain standard operating procedures, compliance checklists, internal forms, logs, and supporting documentation related to pharmacy operations, controlled substances, privacy, documentation standards, and record retention.
• Review claim-related documentation for Medicare, Medicaid, and commercial third-party prescriptions, including prior authorization support, rejection tracking, refill-history support, and record-retention requirements, to strengthen reimbursement compliance.
• Analyze recurring documentation issues, workflow exceptions, audit findings, and compliance trends using PrimeRx, Excel, and related records, and prepare summaries and recommendations for process improvement.
• Monitor pharmacy-related regulatory updates, including changes affecting documentation standards, controlled-substance compliance, privacy requirements, claims documentation, and pharmacy operational procedures, and assist in implementing required changes.
• Support pharmacy compliance efforts related to fraud, waste, and abuse prevention by reviewing documentation patterns, identifying irregularities, and escalating concerns requiring pharmacist review or further investigation.
• Assist with recall monitoring, documentation review, and related recordkeeping for affected prescription drugs, over-the-counter products, and pharmacy inventory to support regulatory compliance and patient safety.
• Apply knowledge of pharmacology and toxicology to support review of medication-related documentation, controlled-substance handling risks, patient-safety considerations, and compliance issues involving high-risk or sensitive medications.
• Coordinate with pharmacists, technicians, and administrative staff to resolve record discrepancies, obtain missing compliance documentation, support staff compliance guidance, and maintain inspection readiness under the direction of the Supervising Pharmacist / Head Pharmacist, with no direct reports.

Bachelor Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Pharmacology/Toxicology