Regulatory & Compliance Specialist at TwelveStone Health Partners

Description

Who We Are:

TwelveStone Health Partners is focused on the medication needs of patients with chronic, complex and rare conditions. For more than 35 years, TwelveStone Health has been dedicated to finding new ways to deliver care designed around the patient. Chronic conditions include Multiple Sclerosis, NMOSD, Myasthenia Gravis, CIDP, ITP, Migraine Prevention, Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Alpha 1 Antitrypsin Deficiency, Primary Immunodeficiency, hATTR Amyloidosis, Thyroid Eye Disease, and many others.

For patients, we provide access to the most advanced medications, along with the personal and financial support patients need to live with chronic conditions. For providers, we simplify treatment for complex conditions by eliminating the administrative and clinical burdens placed on your practice when patients need innovative specialty medications.

TwelveStone Health Partners supports the transition from acute to post-acute care environments and the journey from sickness to health. We are currently licensed in 50 states.

Summary

We are currently hiring for the position of Regulatory & Compliance Specialist. This position helps keep our organization running safely and compliantly by managing licensing requirements, monitoring regulatory obligations, and supporting staff education. This role ensures our teams stay aligned with state, federal, and accreditation standards, contributes to quality and compliance initiatives, and helps maintain a strong culture of accountability and continuous improvement, while promoting a culture focused on patient safety, ethical practices and legal compliance.

Essential Duties & Responsibilities

• Audits, monitors, and tracks organizational compliance activities, including personnel trends, complaints, and quality event patterns. Maintains compliance files and prepares required reports for state, federal, and other regulatory bodies to effectively manage and reduce compliance risks.
• Conducts gap analyses, corrective action plans and follow-up mechanisms to address areas of non-compliance. Prepares and maintains compliance reports and coordinates onsite inspections. Tracks certifications, competencies, ongoing training, and continuing education. Performs site compliance audits and inspections as needed.
• Manages licenses for all lines of business (e.g., infusion centers, pharmacy, home infusion), including initial applications, renewals, and responses to regulatory inquiries.
• Manages professional licenses and certifications for employees (e.g., nurse practitioners, registered nurses, pharmacists, pharmacy technicians), including coordination of pre-hire licensure and credentialing information, obtaining primary source verification (PSV), tracking expirables, and sending staff reminders.
• Supports compliance awareness efforts and assists with the development and delivery of employee training to promote a strong culture of compliance.
• Participates in the Quality Assurance and Ethical Committee and Compliance teams. Reviews and reports on key metrics, findings, quality events, and other compliance requirements.
• Performs other duties as assigned.
  
  

Requirements

Education: High school diploma or GED required. A current, unrestricted pharmacy technician license and certification in the state of practice is preferred.

Experience: A minimum of 5 years of experience in healthcare, pharmacy, or regulated clinical setting, with demonstrated knowledge of regulatory requirements, accreditation standards, and compliance-related duties.

Functional Competencies: Critical Thinking, Problem Solving, Attention to Detail, Precision, Organization. Prioritization, Written and Verbal Communication, Collaboration, Cooperation, Flexibility, Initiative, Focus, Multi-tasking.