Associate Compliance Counsel Duties: Reports to the Senior Compliance Counsel in the Corporate Compliance section of the Ethics & Compliance Department. Supports the development and implementation of programs to ensure compliance with federal and state laws governing the pharmaceutical and medical device industries, including, but not limited to, the Anti-Kickback laws, the FCA, FDCA, FDAMA, PDMA, HIPAA, FCPA, and federal and state Sunshine laws. Creates and updates policies, business rules, and training to support an effective compliance program, reinforce adherence with industry codes (PhRMA Code, AdvaMed Code, etc.), and foster a culture of integrity. Monitors federal and state legislation, guidance, and enforcement activity; assesses business risk; and develops mitigation strategies and tactics. Provides guidance to business partners including Marketing, Sales, and Commercial Operations on compliance policies and remediation activities. Tracks and operationalizes compliance with state laws and regulations on drug price transparency, representative licensure and disclosure, limitations on transfers of value, etc. Supports industry benchmarking initiatives and analyses. Develops and presents compliance training to field-based Commercial colleagues. Develops and delivers training or other methods to ensure all colleagues are educated regarding current developments in compliance, including developing tools for use by the Ethics & Compliance Department. Provides support for field monitoring and record auditing activities as needed. Provides additional support to the Ethics & Compliance team as needed.
Qualifications: Juris Doctorate Degree. 3+ years of substantive experience in life sciences commercial compliance, in-house at a pharmaceutical or medical device company and/or at a firm counseling life sciences industry clients. In-depth understanding of US healthcare industry laws and regulations. Demonstrated achievement monitoring and mitigating regulatory risk and fostering a culture of compliance. Strong interpersonal, writing, communication, organizational, project management and presentation skills. Experience in handling confidential and sensitive situations or information with an ability to exercise a high degree of judgment and discretion.
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