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Healthcare Lawyer (340B)

Healthcare Lawyer (340B)

Vivo HealthStaffBerkeley, CA, US
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Job Description

Job Description

About the Role :

We are seeking a highly skilled and detail-oriented Contract Attorney or Paralegal with expertise in the 340B Drug Pricing Program to join our team on a remote, contract basis. This role will provide critical legal and regulatory support to ensure compliance with 340B program requirements, assist with audits, and help navigate complex legal issues related to pharmaceutical pricing and healthcare regulations. The ideal candidate will have a strong background in healthcare law, contract review, and regulatory compliance, with specific experience in the 340B program.

Key Responsibilities :

  • Provide legal analysis and guidance on 340B program compliance, including eligibility, contract pharmacy arrangements, and regulatory changes.
  • Review, draft, and negotiate contracts related to the 340B program, including agreements with covered entities, contract pharmacies, and third-party administrators.
  • Assist with internal and external audits, including preparing documentation, responding to inquiries, and ensuring compliance with 340B program requirements.
  • Monitor and interpret federal and state regulations, guidance, and policies related to the 340B program and healthcare compliance.
  • Collaborate with internal stakeholders, including legal, compliance, and pharmacy operations teams, to address legal and regulatory risks.
  • Conduct legal research and prepare memoranda on issues related to the 340B program, healthcare law, and pharmaceutical pricing.
  • Support dispute resolution efforts, including responding to HRSA (Health Resources and Services Administration) inquiries or allegations of non-compliance.
  • Stay up-to-date on industry trends, litigation, and enforcement actions related to the 340B program.

Qualifications :

  • For Attorneys : Juris Doctor (JD) degree from an accredited law school and active bar membership in good standing in any U.S. state.
  • For Paralegals : Paralegal certification or equivalent experience, with a strong background in healthcare law or regulatory compliance.
  • Minimum of 1-2 years of experience working with the 340B Drug Pricing Program, healthcare compliance, or pharmaceutical law.
  • In-depth knowledge of 340B program regulations, HRSA guidelines, and related federal and state laws.
  • Experience drafting, reviewing, and negotiating contracts, particularly in the healthcare or pharmaceutical industries.
  • Strong analytical skills with the ability to interpret complex regulations and provide actionable recommendations.
  • Excellent written and verbal communication skills, with the ability to communicate legal concepts to non-legal stakeholders.
  • Self-motivated and able to work independently in a remote environment.
  • Proficiency with Microsoft Office Suite and legal research tools (e.g., Westlaw, LexisNexis).

    • Preferred Qualifications :

  • Experience working with covered entities (e.g., hospitals, clinics, federally qualified health centers) or contract pharmacies.
  • Familiarity with Medicaid drug rebate programs and other pharmaceutical pricing regulations.
  • Prior experience supporting 340B program audits or dispute resolution processes.
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