• Associate Director, Corporate Counsel

    Amneal Pharmaceuticals (Bridgewater, NJ)


    Description:

    The Commercial Counsel will be an integral member of the Amneal Legal team and will serve as a trusted legal advisor for all commercial activities involving the company's specialty, biosimilar and generic products. The incumbent will serve as a member of Amneal's promotional assets review committee (PARC), draft/review/negotiate general commercial and other types of contracts, and handle market access/customer-facing contracting.

    Essential Functions:

    + Advise on a broad array of issues relating to the marketing and promotion of pharmaceutical products and actively represent Legal on the company PARC to review promotional/non-promotional materials and strategies covering multiple topics (disease awareness, patient education/access/support, press releases, interactions with HCP and payers, etc.) to ensure that materials and strategies are compliant with legal and regulatory requirements as well as with internal company policies.

    + Negotiate, draft, review general commercial and other contracts including HCP consultant and speaker agreements, vendor and service provider MSAs and SOWs, and liaise with internal clients and Legal colleagues to finalize same.

    + Counsel on FDCA and other applicable laws and regs. (including federal and state anti-kickback statutes, FCA, FCPA, FDA regulations, OIG guidance, PhRMA Code, Federal healthcare programs, state drug transparency laws, HIPAA/privacy, etc.).

    + Negotiate, draft, and review market access/customer-facing contracts including product purchase, supply, distribution, PBM, GPO, wholesaler/distribution, rebate/discount, and specialty pharmacy agreements. Provide legal guidance on contracting and strategy for established and newly launched products.

    Additional Responsibilities:

    + Analyze and solve problems, often without supervisory input, and provide well‐reasoned, timely, and practical advice to inform business decision-making.

    + Prioritize the development of collaborative relationships with internal stakeholders.

    + Possess solid understanding of drug pricing and reimbursement in the US marketplace and knowledge of US pharmaceutical laws (including federal and state anti-kickback statutes, FCA, FCPA, FDCA, FDA regulations, OIG guidance, PhRMA Code, Federal healthcare programs, state drug transparency laws, HIPAA/privacy, and other applicable laws) and be able to apply such laws to inform business activities.