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Senior Counsel, Head Of Compliance
Refer job# LUFN148701
 
Senior Counsel, Head of Compliance Duties: Design Compliance Program structure in line with the OIG Compliance Program Guidance for Pharmaceutical Manufactures. Establish policies, procedures and systems to foster compliance with healthcare fraud and abuse, privacy, and transparency reporting laws, as well as industry codes, such as the FDCA, Federal Anti-kickback Statute, Federal False Claims Act, HIPAA, GDPR, US Sunshine Act, US state reporting and compliance laws, and US PhRMA Code. Develop and deliver comprehensive compliance training to employees and designated third parties on applicable Compliance policies, laws and regulations, including any new developments or updates that may impact the Compliance Program. Conduct periodic internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures are followed and the Company stays abreast of potential compliance risks and remediates where necessary. Coordinates an enterprise-wide risk management approach with other functions to ensure potential compliance risks to the Company are identified to senior management, appropriately prioritized and mitigated. Partner with internal and external stakeholders with the conduct and resolution of potential compliance investigations, including the management of any resulting corrective actions plans. Institute and maintain effective compliance communication channels for the Company by promoting awareness and retention of the Code of Conduct, the use of the Compliance Helpline, as well other means for employees to report compliance-related concerns or engage with senior leadership. Advise Medical, Commercial, and Communications teams on the development of all disease awareness and product materials to support compliance with regulatory requirements relating to the advertising and promotion of prescription drug medicines. Regularly educate and inform the Companys senior management and, where appropriate, the Board of Directors or a subcommittee thereof, on matters related to the Compliance Program as well as relevant healthcare industry legal and compliance developments. As needed, recruit, manage and develop Legal and Compliance staff to support the Compliance Program and staff members individual development goals. Develop, manage and execute an annual Compliance Workplan, including functional objectives, strategic priorities and operating budget.

Requirements: JD Degree from an accredited law school. Admission to a state Bar. 10+ years' practicing law in a pharmaceutical or biotechnology company legal department and/or well-recognized law firm or healthcare regulatory authority. Experience in a management position within the healthcare compliance function at a pharmaceutical or biotechnology company with marketed products. Experience in designing, building, and implementing a successful compliance program in a pharmaceutical or biotechnology company. Significant experience interacting with Commercial, Medical Affairs, and Research & Development organizations and handling complex compliance issues. Specific expertise in the U.S. Food and Drug Administration advertising and promotion regulations, FDCA, False Claims Act, Anti-Kickback Statute, OIG Guidance, foreign anti-bribery laws, privacy laws, and US and EX-US transparency reporting laws and industry codes (e.g., US PhRMA Code, EFPIA Code of Practice, Sunshine Act).
 
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