Sr. Counsel

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Sr. Counsel
The candidate will be working within the Global Therapeutic Area Legal Support (“GTAL”) team. Will serve as a strategic partner, and legal and compliance resource to the commercial business to ensure appropriate and compliant promotional practices under applicable FDA and other statutory and regulatory requirements. Under appropriate supervision and in collaboration with colleagues on the GTAL and US Pricing & Access, Commercial Legal teams, this attorney will take substantial responsibility for ensuring appropriate interactions with healthcare providers and others, and reviewing and monitoring promotional materials and activities, as well as business strategies and tactics, associated with one of the company's discrete therapeutic areas. Will contribute to the periodic review, revision and supplementation of corporate and commercial compliance policies, procedures, training and monitoring to ensure they appropriately reflect legal and regulatory developments. Will also support Medical Affairs as well as Public Affairs, and other company departments as needed, and contribute legal input to cross-functional groups and projects as they arise. Responsibilities include, but are not limited to: Appropriately triage a heavy workflow, setting appropriate priorities with clients and delivering results within the reasonable agreed timelines. Should have advance a positive spirit of solution-oriented partnership and collaboration with internal clients, internal legal colleagues and outside counsel. Must have Juris Doctorate from a nationally accredited law school. Should be a member in good standing of the State Bar of California, or ability to acquire status of Registered In-House Counsel from the California Bar. Must have 6+ years prior in-house or law firm experience providing legal counsel on the laws and regulations relating to drugs or devices, demonstrating growth and ability to succeed. Detailed knowledge of Food and Drug Administration and other government regulation of marketing and advertising of pharmaceutical products is very helpful. Must have familiarity with these additional areas is also helpful: Anti-Kickback Statute, False Claims Act, HIPAA, privacy-laws, advertising laws and regulatory guidances, and legal contract principles. Must have demonstrated high EQ and client-service orientation; able to recognize and respond quickly and pragmatically to urgent situations and demanding clients.

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