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ProfileAssociate Director, Compliance Counsel/Attorney The candidate will report to and assist the Senior Director, Compliance Counsel for Investigations and Monitoring to ensure full compliance with all applicable laws and regulations. Responsible for providing compliance legal support that may include the company’s R&D, clinical development/operations and medical affairs groups, coordinating and conducting compliance investigations, providing support related to the Company’s antibribery, anticorruption program, and developing and enhancing relevant policies and supporting other compliance program related activities. Provide compliance legal support to the R&D, clinical development/operations and medical affairs organizations by collaborating with members of these organizations and the lead attorney for these groups to: Analyze compliance issues when they arise for process and controls gaps and improvements; Conduct trend analysis and monitoring, as needed, in collaboration with the Compliance Monitoring Team; Develop polices, recommend controls and processes to mitigate risk and remediate compliance issues. Assist with coordinating investigations. Provide counseling on a wide variety of compliance issues related to, among other areas, publications, investigator-initiated studies, data integrity, conflict of interest and code of conduct issues. Provide legal support to stakeholders on laws, codes and regulations relevant to the biotech/pharmaceutical industry including anti-bribery/anti-corruption, anti-kickback laws. Respond to alleged violations of policies, procedures, and standards of the company’s Code of Business Conduct and Ethics by evaluating or recommending the initiation of investigative procedures; Lead investigations of allegations of violations of law or policy, as may be needed. Provide input into and develop, as needed, policies, procedures and guidance documents. Lead and assist in developing and delivering effective training, including written materials, computer-based instruction and live presentations to the extent necessary on various topics including the investigations process and the company’s ABAC program. Help identify potential areas of compliance vulnerability and risk; develop/implement corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future. Law degree from an accredited institution and 5+ years of experience in the legal profession, with 2+ years working in or with pharmaceutical companies on healthcare compliance related activities required. Experience with pharmaceutical/biotech drug discovery, development and manufacturing issues preferred. In-depth knowledge of anti-kickback, anti-bribery prohibitions as they apply to pharmaceutical sales, off-label/inappropriate promotion issues, Open Payments Act reporting obligations, and Medicaid, Federal Supply Schedule and other primary laws governing key pharmaceutical compliance areas required. Extensive experience and skill at writing policies and guidance documents supporting various business activities and conducting investigations required. Experience working with teams across full corporate structure required.
Requisition ID: 8778BR