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Director, Compliance Counsel
Refer job# DBSU141638
 
Director, Compliance Counsel The candidate supports the compliance function and is responsible for assisting in the development, execution and continuous improvement of the compliance program to ensure compliance with all applicable standards, laws, and regulations, including the U.S. Anti-Kickback Statutes, the False Claims Act, the Stark Laws, the Sunshine Act (Open Payments), the FCPA and HIPAA. Supports the Chief Compliance Officer with respect to commercial legal and compliance matters and activities as well as other Legal projects as needed. Monitors activity to help ensure compliance with PhRMA Code with respect to HCP interactions. Provide advice and training to employees of the Company on the health care compliance program using a solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues and laws pertaining to interactions with healthcare providers. Provide legal support for wide range of commercial and medical affairs activities related to product launch and ongoing promotion of pharmaceutical products. Provide legal guidance to Promotional Review Committee. Provide legal guidance to Medical Review Committee. Provide legal guidance to Grants Committee. Stay current on applicable law, regulation, and practice and communicating senior management apprised of current developments.

The candidate should have BA/BS degree and JD degree. Should have 3-5 years of commercial compliance experience, including prior in-house experience with a biotech/pharmaceutical company. A solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues needed. A solid understanding of laws pertaining to interactions with healthcare providers (Anti-Kickback, False Claims etc.) essential.
 
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