Job Description

We are seeking a healthcare attorney with deep expertise in specialty pharmacy operations, pharmaceutical law, and healthcare regulatory compliance, particularly in the context of drug manufacturers and patient support hubs. The ideal candidate will have 510 years of experience advising specialty pharmacies, pharmaceutical manufacturers, or healthcare organizations on complex legal and regulatory matters. This role requires advanced knowledge of HIPAA, HITECH, FDA, CMS, and state pharmacy board regulations, as well as a strong understanding of the legal frameworks governing specialty drug distribution, reimbursement models, manufacturer-sponsored patient services, and compliance programs. Experience with TCPA, SMS/text messaging compliance, and patient communications is essential.

Key Responsibilities:

• Provide strategic legal counsel on healthcare regulatory matters, including HIPAA, HITECH, TCPA, and state privacy laws.
• Advise on specialty pharmacy operations, including distribution models, reimbursement pathways, and patient support programs.
• Draft, review, and negotiate contracts with pharmaceutical manufacturers, patient services hubs, payers, PBMs, and healthcare providers.
• Support compliance initiatives related to manufacturer-sponsored programs, including copay assistance, prior authorization support, adherence programs, and patient engagement platforms.
• Ensure compliance with federal and state laws governing patient communications, including SMS/text messaging under TCPA and related privacy regulations.
• Monitor and interpret changes in federal and state laws affecting specialty pharmacy and pharmaceutical manufacturer relationships.
• Collaborate cross-functionally with compliance, operations, marketing, and patient services teams to ensure regulatory alignment and mitigate risk.

Qualifications:

• Juris Doctor (JD) from an accredited law school.
• Licensed to practice law in at least one U.S. jurisdiction.
• 510 years of legal experience in healthcare law, preferably with a focus on specialty pharmacy, pharmaceutical manufacturers, or patient services hubs.
• Strong understanding of FDA, CMS, TCPA, and state pharmacy board regulations.
• Proven experience in contract negotiation and drafting, especially with pharmaceutical manufacturers and specialty pharmacies.
• Excellent analytical, communication, and interpersonal skills.
• Ability to manage multiple priorities in a fast-paced, evolving regulatory environment.

Preferred Experience:

• Prior in-house counsel experience in a specialty pharmacy, pharmaceutical company, or patient services hub.
• Familiarity with value-based care models, 340B programs, and specialty drug reimbursement strategies.
• Experience with healthcare fraud and abuse laws, including the Anti-Kickback Statute and Stark Law.
• Knowledge of legal issues surrounding patient support programs, hub services, manufacturer-sponsored initiatives, and patient communications platforms.
• Experience advising on TCPA compliance, including opt-in/opt-out protocols, consent management, and SMS campaign oversight.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting

• Industries

  Pharmaceutical Manufacturing

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