Associate Legal Counsel - Corporate Commercial

JOB DESCRIPTION

Description:

The Associate Director, Corporate Counsel - Commercial Contracts, as an integral member of the Amneal Legal team, will serve as the 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, will serve as a member of Amneal's promotional assets review committee (PARC), and provide legal support on REMS related matters.

Essential Functions:

• Negotiate/draft/review market access/customer-facing contracts including product sales, supply, distribution, PBM, GPO, wholesaler/distribution, rebate/discount, and specialty pharmacy agreements. Provide legal and strategic guidance on contracting and strategy for established and newly launched products. Advise on contract disputes. Counsel on FDA law and other laws and regs. such as the IRA, AKS, privacy, and FCA. Support govt. price reporting function.
• Actively represent Legal on the company PARC to review promotional/non-promotional materials and strategies (covering multiple topics including 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. Advise on a broad a broad array of issues relating to the marketing and promotion of pharmaceutical products.
• 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 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 on current FDA regulations and guidance regarding REMS operations.

Additional Responsibilities:

• Analyze and solve problems, often without supervisory input, and provide wellreasoned, 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.

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.

QUALIFICATIONS

Education:

• 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 in Able to effectively partner with internal clients to identify and understand their business requirements and negotiate contracts in accordance with those requirements and the Companys overall objectives and policies.
• 5 years or more in 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;
• 5 years or more in Strong knowledge and experience with drafting/reviewing/negotiating product purchase, rebate/discount, GPO, wholesale distribution, and supply agreements with a wide range of Amneal's customers and industry partners.
• 5 years or more in Experience with drafting/reviewing/negotiating MSAs, NDAs, HCP and non-HCP consulting agreements, IT services, data purchase and other types of agreements, amendments and SOWs
• 3 years or more in Experience with reviewing promotional/non-promotional materials and strategies (covering multiple topics including disease awareness, patient education/access/support, 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 and advise on a broad array of issues relating to the marketing and promotion of pharmaceutical products.
• 3 years or more in Collaborate with other attorneys and assist with special projects and contracting across franchises as workload necessitates.

Skills:

• Possess excellent legal judgment, communication skills and business acumen. - Advanced
• Inspire confidence through the strength of her/his judgment, leadership style, and ability to manage interpersonal relationships with Senior Management, and multiple corporate functional business units, including Market Access/Commercial Teams, Finance, Compliance, Marketing, Medical Affairs, and Regulatory. - Intermediate
• 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
• Possess a continuous improvement and innovative mindset; open to new ideas and ways to maximize efficiencies and optimize processes. - Intermediate
• REMS-related experience. - Beginner