Regulatory & Compliance Analyst
Regulatory & Compliance Analyst needed to perform the following duties:
- • Coordinate and document Internal Regulatory processes such as Internal Audits, Registrations, License Renewal, and Inspections.
- • Plan, Direct and Coordinate activities of an Organizations to ensure compliance with Federal and State Ethical and Regulatory Standards.
- • Develop, Implement and Enforce policies & Stored procedures that keep a company’s products, processes and physical sites operating in a legal & ethical manner.
- • Create spreadsheets and reports, analyze data and sample for compliance
- • Verify Prescriptions for correct drug name, strength, direction, DAW Codes, date written, Prescriber name and associated NPI/DEA and to make sure all state and federal prescription requirements are met
- • Updating Inventories for regular and controlled medicines every 6 months and assist in returning the medications in a legal way
- • Help uncover unnecessary costs to the insurance system by taking a close look at billing practices that include billing units, refill practices, overrides, partial fill procedures, package size selection, and proof of documentation. If the following self-audits steps reveal potential overpayments, the self – audit guidelines explain steps that must be followed.
- • Monitor and Evaluate FDA enforcement activities including 483s, warning letters and EIRs (Establishment Inspection report)
- • Monitor quality and compliance regulations impacting overall stokes operations to quickly identify appropriate actions to take to position stokes pharmacy for continued compliance
- • Serve as a resource for all external third-party payer audits, gathering information, as appropriate, to ensure prompt and enough response.
Bachelor’s Degree required in Drug regulatory affairs or Public Administration or Pharmacy or Pharmaceutical Science or Pharmaceutics