Description
JOB 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 handle market access/customer-facing contracting, draft/review/negotiate general commercial and other types of contracts, serve as a member of Amneal's promotional assets review committee (PARC), and provide legal support on REMS related matters.
This position follows a hybrid work model, requiring at least 3 days per week on-site at our Bridgewater, NJ location.
Essential Functions
- 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.
- 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.
- Participate in multi-sponsor REMS Legal subcommittee meetings. Review PMO and related vendor agreements, operating budgets, and various reports. Advise on REMS operations, prescriber disputes, industry and FDA developments. Stay current on FDA regs. and guidance regarding REMS operations.
- 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.). Support state and Federal govt. price reporting functions.
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 and maintain solid understanding of drug pricing/reimbursement in the US marketplace, strong knowledge of US pharmaceutical laws, and be able to apply such laws to inform business activities.
Education
QUALIFICATIONS
- Bachelors Degree (BA/BS) - Required
- Juris Doctor or equivalent and admitted to and in good standing with the bar of at least one state in the US - Required
Experience
- 5 years or more experience with drafting, reviewing and negotiating market access/customer-facing contracts including product purchase, supply, distribution, PBM, GPO, wholesaler/distribution, rebate/discount, and specialty pharmacy agreements with a wide range of Amneal's customers and industry partners. - Required
- 5 years or more experience with drafting/reviewing/negotiating MSAs, NDAs, HCP/non-HCP consulting agreements, IT services, data purchase and other types of agreements, amendments and SOWs - Required
- 3 years or more experience in reviewing promotional/non-promotional materials and tactics and advising on a broad array of issues relating to the marketing and promotion of pharmaceutical products. - Required
- 5 years or more experience in effectively partnering with internal clients to identify and understand their business requirements and negotiate contracts in accordance with those requirements and the Company’s overall objectives and policies. - Required
- 5 years or more experience working in a law firm and/or as in-house counsel with a pharmaceutical, medical device or drug/device wholesale distributor – including direct experience working closely with the sales or commercial function of such organization. - Required
Skills
- Ability to draft, review, negotiate, and manage multiple types of commercial agreements. - Advanced
- Ability to work comfortably in an intense, fast-paced environment; responsive to the needs of her/his business partners and execute under pressure in a timely way; comfortable working with compressed timelines. - Advanced
- Strong team player; desire to work as a member within a highly collaborative Legal Dept., partnering with other legal colleagues to execute company objectives as well as to provide quality legal services to internal business clients. - Advanced
- Inspire confidence through the strength of her/his judgment, leadership style, and ability to manage interpersonal relationships with Senior Management, and partner with multiple corporate functional business units, including Market Access/Commercial Teams, Finance, Compliance, Marketing, Medical Affairs, and Regulatory. - Advanced
- Possess a continuous improvement and innovative mindset; open to new ideas and ways to maximize efficiencies and optimize processes. - Intermediate
- REMS-related experience. - Beginner
About Us
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
