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In-House
Attorney
Biotechnology
Pharmacology
8-10 yrs required
Associate General Counsel The candidate will draft, negotiate, and counsel business on agreements, including but not limited to: GPO, distributor, IDN, specialty pharmacy and other customer agreements, service provider and consulting agreements, and other complex commercial transactions. Advise management and brand teams on legal matters within the following areas: Government Pricing; Government Contract Compliance (e.g., Army Bases, DOD, VA FSS); Government Matters (e.g., AG, CMS, DOJ, FDA, HRSA, OIG, VA); VA Subcontractor Agreements; 50-state surveys; Tiered Agreement support; State Licenses and Business Registrations; Product Issues (e.g., Customer Complaints, Pharmacovigilance, Recalls, Transportation); Intellectual Property. Manage a direct report by supporting the growth and development of a Paralegal.
Qualification and Experience
The candidate should have a BA/BS (or equivalent) degree from an accredited school. J.D. degree and Bar Admission (or limited in-house license) in NJ (and NY, preferred). Minimum of 8-10 years of experience serving in a legal or related role, with a majority of that experience in the pharmaceutical/medical device/biotechnology industries (plasma protein industry experience preferred). In-house or large pharmaceutical consulting firm experience required. Substantial knowledge and understanding of the various laws, regulations and industry guidance that affect pharmaceutical and bio-pharmaceutical companies including FDA, FTC, HIPAA, Medicare/Medicaid and antitrust matters. Experience as lead counsel on advertising and promotional review committee, reviewing all sales and marketing materials and initiatives, including anticipated product launch, and advising on regulatory issues. Be a collaborative member of the US Legal team offering support to other team members, involvement in legal projects, and sharing knowledge of research on industry trends and other topics. Ethical, with a strong understanding of legal risks and a good sense for practical, creative solutions and flexibility. Proactive, responsive and resourceful. Excellent written, oral and presentation skills. Ability to listen carefully and effectively communicate complex topics with different types of potential clients. Demonstrated ability to quickly establish trust and rapport with other personnel at all levels across all departments. Efficient at handling and prioritizing multiple projects in a service-oriented environment.
Requisition ID : 1218
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