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Years of Experience
Date Last Verified
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. In particular the Compliance Attorney will be responsible for providing compliance legal support that may include 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. The position will interact with departments across company. 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 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 company’s ABAC program. Keep apprised of legislative and regulatory developments and inform and advise the compliance department on areas of risk and potential steps to reduce risk. 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.
Qualification and Experience
The candidate should have law degree from an accredited institution. Must have 5 years' experience in the legal profession, with 2 years working in or with pharmaceutical companies on healthcare compliance related activities. Should have experience with pharmaceutical/biotech drug discovery, development and manufacturing issues preferred. Must have 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. Should have extensive experience and skill at writing policies and guidance documents supporting various business activities and conducting investigations. Must have ability to write clearly and prepare professional communications related to administrative processes, risk assessments and audit and investigation findings. Should have experience working with teams across full corporate structure.
Requisition Number: 8778BR