Regulatory Compliance Analyst

BrightSpring Health Services•Louisville, KY

About The Position

The Regulatory Compliance Analyst supports the Pharmacy Compliance Team by conducting routine and random compliance audits at pharmacy locations and helping ensure pharmacy activities and operations comply with applicable state and federal laws and regulations. The role also supports pharmacy operations teams by responding to compliance and regulatory questions based on operational needs. The analyst conducts on-site, virtual, and desktop audits across pharmacy locations nationwide, including data-entry, focus, and records audits. The role assists with developing and maintaining audit and risk-assessment tools, investigates compliance matters under the direction of the Vice President of Pharmacy Compliance, and provides timely analysis and recommendations to operational leadership. It also monitors regulatory and industry developments, supports regulation-impact research and implementation, reviews and triages compliance concerns, and develops and presents compliance training and updates. Regular reports and updates on compliance matters are provided to the Vice President of Pharmacy Compliance. The position requires maintaining applicable licenses or certifications in good standing, following Company policies and ethical standards, and approaching work in a friendly, positive, and team-oriented manner. Travel is required more than 50% of the time, by plane or vehicle, with overnight stays as needed. A South to West home-office location is preferred, as is access to a major airport.

Requirements

Two years of experience in pharmaceutical regulatory or related industry 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 needed.
Experience working with multiple regulatory functions and cross-functional teams.
Proficiency with Microsoft Office products.
Maintain required licenses or certifications in good standing.

Nice To Haves

Certified Pharmacy Technician registration.
Healthcare Compliance Certification.
South to West home-office location.
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/or desktop audits of pharmacy locations nationwide, 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 Vice President of Pharmacy Compliance.
Ensure compliance with state and federal laws and regulations related to pharmacy operations.
Stay current on industry regulations and accreditation standards; monitor regulatory changes, HHS Guidelines, HHS Work Plans, and emerging industry trends to revise 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 complaints, concerns, or questions related to compliance and provide consultative leadership and support to entities as appropriate.
Develop and present regulatory and compliance topics to pharmacy operations team members.
Develop and provide regular compliance reports and updates to the Vice President of Pharmacy Compliance.
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.
Maintain required licenses or certifications in good standing and perform duties with a friendly, positive, and team-oriented approach.