Senior Corporate Counsel Manager

Amneal PharmaceuticalsBridgewater Township, NJ
4d

About The Position

The Senior Manager, Corporate 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 related 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. Counsel on FDCA and other applicable laws and regulations (including federal and state anti-kickback statues, FDC, FCPA, FDA regulations, OIG guidance, PhMRA Code, Federal health care programs, state drug transparency laws, HIPAA/privacy, etc.) Negotiate, draft, review general commercial and other contracts including HCP consultant and speaker agreements, vendor and service provider MSAs and SOWs such as licensing agreements, software agreements, standard confidentiality and non-disclosure agreements, R D and clinical trial agreements 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.

Requirements

  • Bachelors Degree (BA/BS) - Required
  • Juris Doctor L.L.M. or J.D. from accredited U.S. law school - Required
  • Must have at least 5 years of legal experience with proven ability to work independently or with minimal supervision from attorneys.
  • 4 years of pharmaceutical experience with experience reviewing promotional material and drafting, reviewing, negotiating a wide array of contracts.
  • Highly organized and able to independently administer department procedures and carry out projects with minimal supervision under pressured circumstances. - Advanced
  • Strong ability to independently problem solve, take initiative to assist others and find creative solutions. - Advanced
  • Strong ability to manage a complex project from inception to completion with limited guidance and oversight. - Advanced
  • Ability to maintain strict confidentiality, exercising discretion and independent judgment on matters of significance. - Advanced
  • Superior communication and interpersonal skills and ability to effectively communicate with all levels of individuals within and outside the company, including an in international environment. - Advanced
  • Expertise in performance of legal analysis and problem solving. - Advanced
  • Ability to multi-task and handle multiple interruptions and adjustments to priorities throughout the day, including the ability to perform multiple projects for a variety of people while organizing and meeting deadlines. - Advanced
  • Team player willing to pitch in as needed in all department matters. - Advanced
  • Ability to gather and analyze due diligence and other legal materials, such as statutes, decisions, and legal articles, codes, and documents. - Advanced
  • Highly detail oriented and able to quickly and independently identify gaps or risk areas in a complex project. - Advanced
  • Expertise in MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, and Cloud based file sharing programs including databases. - Advanced
  • Exercises independent judgment - Advanced

Responsibilities

  • Advise on a broad array of issues related 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.
  • Counsel on FDCA and other applicable laws and regulations (including federal and state anti-kickback statues, FDC, FCPA, FDA regulations, OIG guidance, PhMRA Code, Federal health care programs, state drug transparency laws, HIPAA/privacy, etc.)
  • Negotiate, draft, review general commercial and other contracts including HCP consultant and speaker agreements, vendor and service provider MSAs and SOWs such as licensing agreements, software agreements, standard confidentiality and non-disclosure agreements, R D and clinical trial agreements
  • 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.
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