Interim Healthcare Compliance Counsel (Pharma)

Company: Major, Lindsey & Africa
Location: Gaithersburg
Posted on: May 3, 2025

Job Description:

Major, Lindsey & Africa's Interim Legal Talent group is seeking an Interim Healthcare Compliance Counsel with a background in the pharmaceutical industry.

Overview: We are seeking an experienced interim Healthcare Compliance Counsel with a background in pharmaceuticals to advise our client's commercial business teams on compliance issues related to both over the counter (OTC) and retail Rx drugs, and to provide general compliance support and oversight to various business units.

Company: East coast-based life sciences organization which develops, delivers and manufactures pharmaceutical products.

Experience: The ideal candidate will have 10 to 15 years of experience advising business partners on compliance issues related to pharmaceuticals and general corporate compliance.

Location: Remote for candidates in the eastern and central US time zones.

Responsibilities Include:

• Opioid Emergency Preparedness (40%)
  • Provide expert guidance on compliance matters related to over the counter (OTC) and retail prescription (Rx) models
  • Regulatory Adherence: Ensure adherence to regulatory requirements for both OTC and Rx products sold to government and quasi-governmental organizations.
  • Partnership Management: Oversee compliance activities related to financial transactions and partnerships with recovery agencies, physicians, and state entities
  • General Compliance (40%)
    • Cross-Department Collaboration: Work closely with departments such as medical affairs, R&D, corporate affairs, and government affairs to ensure comprehensive compliance across all business functions.
    • Risk Identification and Mitigation: Identify and mitigate compliance risks, including corruption and reputational risks, associated with interactions with government officials and agencies.
    • Medical Countermeasures (20%)
      • Compliance Management: Manage compliance for the medical countermeasures business, which includes vaccines sold to government agencies (e.g., anthrax, smallpox, mpox vaccines).
      • Federal Regulations: Ensure compliance with federal regulations and strategic national stockpile requirements.
      • Ethical Business Practices: Monitor interactions with government officials to prevent corruption and ensure ethical business practices
        Qualifications Include:
        • Minimum of 10 years of compliance experience in the pharmaceutical industry, preferably with a focus on compliance issues related to providing pharmaceuticals to governmental and quasi-governmental agencies.
        • Excellent communication and interpersonal skills, with the ability to effectively collaborate with senior personnel from commercial teams, R&D, and other various departments and stakeholders.
        • JD from ABA accredited school and active license in at least 1 US jurisdiction.
          Pay: $115 to $125 per hour, depending on relevant experience, background, and qualifications.
          
          Information regarding benefits can be found on MLA's Website on the Consultant Resources Page:
          
          All interested and qualified candidates should apply directly with Major, Lindsey & Africa for review and consideration.
          Major, Lindsey & Africa does not discriminate against applications on the basis of age, sex, race or any other protected characteristics pursuant to applicable state or federal laws.
          
          Bullhorn Job ID: 221281
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Keywords: Major, Lindsey & Africa, Bowie , Interim Healthcare Compliance Counsel (Pharma), Healthcare , Gaithersburg, Maryland