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Our client, a dynamic and fast growing, publicly-traded biopharmaceutical company in New York, is seeking an Associate Director, Compliance Counsel. The Associate Director, Compliance Counsel 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 Counsel will be responsible for providing compliance legal support, conducting compliance investigations, developing and enhancing relevant policies and additional compliance program related activities.
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.
Provide legal support to stakeholders on laws, codes and regulations relevant to the biotech/pharmaceutical industry and anti-bribery/anti-corruption, anti-kickback and transparency reporting laws and relevant state laws.
Assist in compliance related projects.
Provide input, as needed, into policies, procedures and guidance documents related to various headquarters and field-based business activities.
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.
Provide legal support in connection with the vendor due diligence process.
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.
Law degree from an accredited institution.
At least 5+ years of experience in the legal profession, with at least 2+years working in or with pharmaceutical companies on healthcare compliance related activities.
Extensive experience and skill at writing policies and guidance documents supporting various business activities and conducting investigations.
In-depth knowledge of anti-kickback prohibitions as they apply to pharmaceutical sales, off-label promotion prohibitions, Open Payments Act reporting obligations, and Medicaid, Federal Supply Schedule and other primary laws governing key pharmaceutical compliance areas.
Experience with transparency laws globally and relevant state laws applicable to the pharmaceutical industry.
Ability to write clearly and prepare professional communications related to administrative processes, risk assessments and audit and investigation findings.
Experience working with teams across full corporate structure.
High level of influencing skills and ability to drive change as it relates to implementing remedial actions.
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