The Associate Compliance Counsel will work in collaboration with the rest of the Legal and Compliance team to advise on, develop, implement, and sustain the Corporate Compliance Program. This role will serve as a key member of the Legal and Compliance team, with primary responsibility for providing legal counsel on compliance and legal matters, contributing to the promotional review process, supporting core compliance program operations, and contributing to the development and improvement of procedures, policies, work instructions, training programs, and related initiatives.

PRIMARY RESPONSIBILITIES

Promotional Review:

• Review promotional materials for compliance with applicable U.S. Food and Drug Administration regulations, Federal Trade Commission, and healthcare fraud and abuse laws, including the Anti-kickback Statute and False Claims Act
• Collaborate cross-functionally with promotional material owners to provide legal review, interpretive guidance, and actionable feedback in alignment with company risk tolerance and legal and compliance expectations
• Escalate complex or high-priority items to other members of Legal and Compliance for input and participate in the formulation of recommendations and mitigation strategies
• Develop and maintain key checklists, reference materials, and other documentation to support and standardize the promotional review process
• Serve as a subject matter resource on advertising and promotional laws and regulations

Compliance Risk Assessment, Auditing and Monitoring:

• Conduct and advise on routine risk assessments in coordination with the rest of the Legal and Compliance team as well as other functions within the company.
• Prepare and maintain internal compliance documentation, audits, reports, and logs
• Conduct ongoing monitoring of risk areas in collaboration with other members of the Legal and Compliance team.
• Track updates and changes in federal and state laws affecting company practices and evaluate their impact on policies, procedures, and business operations
• Document auditing and monitoring processes and outcomes
• Provide legal interpretation and recommendations in response to identified compliance risks or audit findings

Policy & Procedure Development:

• Draft and maintain SOPs, compliance policies, and other related documentation to ensure consistency with applicable legal and regulatory requirements
• Research and summarize legal and regulatory updates related to healthcare compliance, FDA and FTC marketing regulations, fraud and abuse laws, and other applicable industry requirements
• Track and maintain updates to applicable legal and regulatory requirements
• Advise internal stakeholders on the practical application of legal and compliance policies and support business-aligned implementation of new requirements

Legal Services and Counsel

• Provide legal counsel on compliance and regulatory matters, including interpretetion and application of federal and state laws, regulations, industry standards, etc.
• Conduct legal research and analysis to support company initiatives, risk assesments, and policy development
• Perform other legal and compliance duties as assigned, including research, drafting, review of contracts and other documents, risk assessments, or other matters in support of the Legal and Compliance functions

Training & Reporting:

• Support the rollout of compliance training programs
• Deliver training to internal staff on topics within the Corporate Compliance Program

ADDITIONAL RESPONSIBILITIES

• Partner with other Legal and Compliance team members for special initiatives and cross-functional projects
• Maintain organized compliance program documentation and support continuous improvement initiatives
• Perform other duties and projects as assigned