Director Legal amp Compliance

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Director, Legal & Compliance
The candidate will support the U.S. compliance program in line with the OIG Compliance Program Guidance for Pharmaceutical Manufactures (OIG Guidance) and industry best practices. Will 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 Food, Drug and Cosmetics Act (FDCA), Federal Anti-kickback Statute, Federal False Claims Act, Health Insurance Portability and Accountability Act (HIPAA), EU General Data Protection Regulations (GDPR), U.S. Sunshine Act and state compliance laws, and U.S. PhRMA Code. Develop and execute a comprehensive compliance training program to U.S. employees and designated third parties on applicable compliance policies, laws and regulations, including any new developments or updates that may impact the Company’s compliance program. Provide compliance oversight and participate, as required, in review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups. Conduct periodic internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended and the Company identifies potential compliance risks and remediates where necessary. Partner with internal (e.g., Legal, Compliance, Internal Audit and Human Resources) and external (e.g., outside counsel or investigators) stakeholders for 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. Serve as primary Legal and Compliance resource for the U.S. Sales Field Organization, Field Medical Directors and Field Market Access teams. Regularly educate and inform the Company’s senior management 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 team members to support the Firm’s Legal and Compliance department and team members’ goals. Develop, manage and execute an annual U.S. Compliance Workplan, including functional objectives, strategic priorities and operating budget. As part of a growing Legal and Compliance team, participate in various projects outside of these primary responsibilities.

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