Regulatory Compliance Analyst

BrightSpring Health Services•Lyndon, KY

About The Position

The Regulatory Compliance Analyst assists the Pharmacy Compliance Team by conducting routine and random compliance audits at pharmacy locations to help ensure operations comply with applicable state and federal laws and regulations. The role supports pharmacy operations teams by responding to compliance and regulatory questions, and develops and provides regular compliance reports and updates to the Vice President of Pharmacy Compliance. The analyst conducts on-site, virtual, and desktop audits across the country; supports the development and maintenance of audit and risk-assessment tools; analyzes compliance issues and recommends actions to operational leadership; investigates compliance matters under the direction of the VP of Pharmacy Compliance; and assists with regulatory research, implementation, training, and other components of the Company Compliance Program. The position also monitors regulatory and industry developments, reviews and responds to compliance concerns, and presents compliance topics to pharmacy operations team members.

Requirements

  • Two years of experience in pharmaceutical regulatory or industry-related work.
  • Ability to review and apply healthcare regulations.
  • Ability to work independently in a remote site.
  • Ability to travel more than 50% of the time by plane or vehicle, including overnight stays as necessary.
  • Experience working with multiple regulatory functions and cross-functional teams.
  • Proficiency with Microsoft Office products.

Nice To Haves

  • Certified Pharmacy Technician registration.
  • Healthcare Compliance Certification.
  • Home office located in the South to West region.
  • Proximity and access to a major airport.

Responsibilities

  • Conduct on-site audits of PharMerica and One Point Patient Care pharmacy locations across the country.
  • Conduct virtual and desktop audits of pharmacy locations, including data-entry, focus, and records audits.
  • Assist in developing and maintaining operations audit and risk-assessment tools for pharmacy audits.
  • Provide timely analysis and recommendations to operational leadership on compliance issues.
  • Investigate compliance matters under the direction of the VP of Pharmacy Compliance.
  • Ensure compliance with state and federal laws and regulations related to pharmacy operations.
  • Remain current on industry regulations and accreditation standards.
  • Monitor regulatory changes, HHS Guidelines, HHS Work Plans, and emerging industry trends to revise, enhance, or develop audit approaches and training.
  • Assist with pharmacy regulation impact research and implementation support.
  • Assist in implementing other components of the Company Compliance Program.
  • Review, triage, or respond to compliance matters received from pharmacy locations.
  • Review compliance-related complaints, concerns, or questions and provide consultative leadership and support to entities as appropriate.
  • Develop and present regulatory and compliance topics to pharmacy operations team members.
  • Support the goals of the compliance team, pharmacies, and the Company.
  • Comply with applicable laws, regulations, ethical standards, and Company policies, procedures, rules, and standards.
  • Perform job duties with a friendly, positive, and team-oriented approach.
  • Maintain required licenses or certifications in good standing.
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