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

Auditing, Reporting, and Documentation

• Assist supervising pharmacist and vice president to prepare regulatory documentation for prescription medications inventory, daily processed claims for prescriptions, and other services like immunization, patient counseling, etc.
• Conduct regular audits of pharmacy records, inventory, and controlled substance handling to identify and mitigate compliance risks.
• Prepare and submit regulatory reports, licensing applications, and renewals to maintain pharmacy operations.
• Maintain accurate documentation of compliance activities, including audit findings, training records, and incident reports.
• Support the implementation of electronic record-keeping and reporting systems to enhance compliance tracking and management.
• Communicate with regulatory agencies for any prescription-related audit. Prepare all the required documentation and assist supervising pharmacist and clinical department team for each claim process with proper documentation and additional information to answer any internal and external audit.
• Keep operating records and proper daily records of transactions for accounting compliance and for insurance claims settlement and daily ledger as per company policies, maintaining the financial transaction record. Ensuring the delivery confirmation and documentation of daily merchandise receiving of inventory. Using accounting software like MS Excel.

Policy Development and Compliance Oversight

• Develop, implement, and maintain policies and procedures to meet regulatory standards and industry best practices.
• Monitor and ensure compliance with federal, state, and local regulations related to pharmacy operations, including DEA and FDA requirements.
• Analyze changes in pharmacy laws and regulations, assess their impact on operations, and recommend necessary adjustments.
• Review insurance claims rejections and make a follow-up for the prior authorization for specialty medication prescriptions with medical providers. Prepare all necessary documentation and data for the patient profile to submit necessary information for the prior authorization approval and resolve payment rejections.

Training and Investigations

• Collaborate with pharmacy staff to provide training and education on compliance policies and regulatory updates.
• Perform market analysis to determine market acceptance of new FDA-approved prescription medications (brand & generic), approved over-the-counter formulations of new products, and surgical products to increase the potential revenue of the organization and business growth.
• Investigate compliance issues, including prescription discrepancies or controlled substance irregularities, and recommend corrective actions.
• Supervise salesclerks and other non-clinical staff, accountable for pharmacy technicians hiring, onboarding, training, and educating for pharmacy compliance policies, and HIPPA law and help them to ensure they complete PAAS training.

Regulatory Agency and Promotional Compliance

• Serve as the primary liaison with regulatory agencies during inspections, audits, and investigations.
• Participate in risk assessment processes and contribute to the development of mitigation strategies for regulatory risks.
• Review and approve promotional materials, labeling, and communications to ensure compliance with applicable standards.
• Prepare and make additional changes in standard operating procedures for clinical staff and nonclinical staff with the help of the vice president to make important changes in business-related decisions and to enhance the efficiency of patient management services.

Degree & Specialization