Chief Compliance Officer

Contact: Jack Weissman
Phone: (267) 541-3091

Position Overview

Our client has entered into a strategic partnership aimed at fostering innovation and providing access to novel antibacterial drugs, particularly those that can be used against biothreats.

Key Responsibilities

  • Healthcare and Corporate Compliance
    • Establish healthcare and corporate compliance program in accordance with FSG guidelines and industry best practices
    • Provide timely, competent and practical advice and support for questions and concerns regarding the compliance program.
    • Review and approval of all our client’s materials/communications, as governed by relevant policies and procedures to ensure compliance with applicable legal and regulatory requirements
    • Liaise with sales, marketing, medical, finance, accounting, internal audit, procurement, human resources, information technology and business development in all compliance related activities. Provide training assistance to teams, as needed.
    • Establish compliance training, auditing and monitoring programs, including, but not limited to, additional support of enterprise risk management activities.
    • Facilitate compliance with state-specific legal requirements and local sales representative/speaker licensing and/or credentialing requirements.
    • Ensure preparation and management of applicable state marketing/transparency reports and Federal Sunshine Act reports as necessary.
    • Develop and/or revise compliance policies, documents, deliverables, and training.
    • Oversee investigations and response to internal or external enforcement actions
  • Business Development and Strategic Initiatives
    • Support strategic initiatives as member of Senior Leadership Team
    • Lead Government Affairs efforts, in collaboration with the Chief Commercial Officer
    • Support evaluation of business development opportunities
    • Support due diligence and integration activities
    • Ensure proper and comprehensive execution of strategic and business development imperatives

Key Requirements

  • Bachelor’s degree in law / relevant area from an accredited university required.
  • 15 – 20 years healthcare compliance experience in the pharmaceutical or medical device
    industry.
  • Demonstrated knowledge and understanding of the required elements of compliance
    programs and applicable industry standards.
  • Awareness of federal fraud and abuse laws and guidance, including the ACCME guidelines,
    the Office of Inspector General reports, and the Food, Drug and Cosmetic Act and an
    understanding of the roles and authority of government agencies and industry cooperative
    groups including FDA, OIG, PhRMA and AdvaMed.
  • Knowledge of people management including recruitment, hiring, progressive discipline
    process and coaching.
  • Certification in Compliance & Ethics and Information Privacy from an accredited organization
    preferred.
  • Important Certifications: The following certifications will prove helpful:
    • International Association of Privacy Professionals Portsmouth, NH
      • Certifications: CIPP/E , CIPP/US
    • Current Society of Corporate Compliance and Ethics Minneapolis, MN
      • Certification: CCEP
    • HCCA CCB Certified in Healthcare
      • Information Mapping – Knowledge Solutions Jacksonville, FL
    • Certification: Developing Procedures, Policies & Documentation
    • Extensive experience in Pharmaceutical guidelines
  • Relevant experience
    • Exceptional communication and collaboration skills, including presentation capabilities, interpersonal skills and conflict resolution.
    • Action-oriented team player.
    • Ability to work independently and with a high level of initiative.
    • Ability to summarize and simplify complex information.
    • Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organization.
    • Must be able to manage complex projects and multiple projects simultaneously.
    • Demonstrated ability to adapt to and lead through changing competitive challenges and market dynamics.
    • Displays a sense of urgency and commitment to achievement of objectives and
      commitment.

Location(s)

Remote

If interested, please send a MS Word version of your resume to [email protected]

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