Compliance Specialist

Overview:

The Compliance Specialist at Strive Pharmacy is responsible for ensuring adherence to all applicable federal, state, and local regulations. This role encompasses accreditation support, telehealth compliance, multi-state dispensing, and shared services to promote safe, compliant pharmacy operations across all locations. Working closely with pharmacy teams, the Compliance Specialist will conduct audits, manage regulatory requirements, and support Strive Pharmacy’s commitment to operational excellence and patient safety.

Location: Remote (EST Coast)

Key Responsibilities:

1. Regulatory Compliance and PDMP Oversight:

• Ensure compliance with all federal and state regulations, including DEA, HIPAA, OSHA, and state board of pharmacy rules.
• Oversee PDMP requirements by reviewing controlled substance prescriptions, identifying irregularities, and training staff on PDMP usage and reporting protocols.
• Stay updated on PDMP regulations and ensure pharmacy policies are adjusted as necessary.

• Assist with achieving and maintaining accreditation from the Pharmacy Compounding Accreditation Board (PCAB) and the National Association of Boards of Pharmacy (NABP).
• Conduct internal reviews to ensure standards align with PCAB and NABP requirements, including compounding processes, quality control, and documentation.
• Coordinate accreditation documentation, audits, and renewals to maintain high standards and operational readiness.

• Ensure compliance with telehealth regulations, focusing on state-specific guidelines and federal requirements.
• Work with telehealth service providers and internal teams to ensure processes meet compliance standards, data security protocols, and patient confidentiality requirements.
• Develop telehealth-specific policies, including patient consent and data handling procedures, to prevent regulatory risks.

• Monitor and ensure compliance with multi-state pharmacy regulations, particularly where Strive Pharmacy dispenses medications across state lines.
• Review dispensing practices to comply with state-specific rules for controlled substances, labeling, and patient counseling.
• Collaborate with state boards and regulatory agencies to ensure all pharmacy locations operate within the bounds of state licensing requirements.

• Oversee shared services agreements to ensure compliance with relevant regulations, such as prescription transfer, remote order processing, and inventory management across locations.
• Develop protocols to ensure consistency in shared service operations, including remote work compliance, quality assurance, and secure data handling.
• Monitor compliance with the Colorado Board of Pharmacy and other relevant state boards’ guidelines on shared services.

• Conduct regular audits of pharmacy operations, including controlled substance management, recordkeeping, and compliance with PDMP and telehealth requirements.
• Monitor multi-state dispensing activities to ensure compliance across all locations and report findings to the Director of Compliance.
• Identify compliance risks and collaborate with teams on corrective actions.

• Develop and update compliance policies and procedures related to PDMP, telehealth, multi-state dispensing, and shared services to align with regulatory standards.
• Ensure policies are integrated into daily operations and maintain documentation to support audit readiness.

• Investigate compliance-related incidents, including medication errors, data breaches, and regulatory violations, ensuring accurate documentation and corrective actions.
• Report incidents to relevant authorities and collaborate with pharmacy staff to resolve issues and prevent recurrence.

• Conduct ongoing compliance training for pharmacy staff, focusing on regulatory updates, PDMP protocols, telehealth requirements, and shared service compliance.
• Develop training materials and assess knowledge retention among staff to ensure adherence to best practices.

• Maintain organized records of compliance audits, accreditation reports, PDMP logs, and incident investigations.
• Prepare compliance activity reports for the Director of Compliance and senior management, highlighting any operational risks or corrective actions.

• Act as the primary point of contact for compliance questions related to multi-state dispensing, telehealth, shared services, and accreditations.
• Liaise with external auditors, regulatory bodies, and accreditation organizations as needed to support compliance efforts.

Qualifications:

• Education:
  • Bachelor’s degree in healthcare, pharmacy, law, or a related field.
  • Advanced degree or certification in compliance or pharmacy (e.g., Certified Pharmacy Compliance Officer, CHC) preferred.
• Experience:
  • 5+ years of experience in pharmacy compliance, regulatory affairs, or healthcare compliance, with experience in PDMP oversight, telehealth, multi-state dispensing, and shared services.
  • Compounding pharmacy compliance experience including sterile and non-sterile
  • USP 795, 797, and 800 knowledge
• Skills:
  • Strong knowledge of federal and state pharmacy regulations, including telehealth and multi-state dispensing.
  • Experience with pharmacy accreditation standards, PDMP systems, and compliance software.
  • Excellent analytical, organizational, and communication skills.
• Personal Attributes:
  • Detail-oriented, proactive, and committed to ethical standards.
  • Ability to work independently, maintain confidentiality, and demonstrate leadership.

Working Conditions:

• Schedule: Full-time; travel to pharmacy locations will be required once a quarter.
• Environment: This role requires interaction in both pharmacy and office settings, with a strong focus on regulatory compliance, patient safety, and accreditation readiness.