Associate Director, Corporate Counsel
Amneal
Summary
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.
Job description
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.
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 of legal experience including in-house counsel experience at a pharmaceutical or biotechnology company and/or law firm experience representing clients in the pharmaceutical, biotechnology, or broader life science industries.
- Experience reviewing promotional/non-promotional materials and tactics and advising on a broad array of issues relating to the marketing and promotion of pharmaceutical products.
- Experience drafting, reviewing, and negotiating a broad range of agreements, including MSAs, NDAs, consulting agreements, clinical trial and other R&D agreements, product purchase, supply, distribution, PBM, GPO, rebate and discount agreements, specialty pharmacy agreements, and IT services and data purchase agreements.
- Demonstrated experience 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.
Requirements
- 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
- 5+ years of legal experience including in-house counsel experience at a pharmaceutical or biotechnology company and/or law firm experience representing clients in the pharmaceutical, biotechnology, or broader life science industries.
- Experience reviewing promotional/non-promotional materials and tactics and advising on a broad array of issues relating to the marketing and promotion of pharmaceutical products.
- Experience drafting, reviewing, and negotiating a broad range of agreements, including MSAs, NDAs, consulting agreements, clinical trial and other R&D agreements, product purchase, supply, distribution, PBM, GPO, rebate and discount agreements, specialty pharmacy agreements, and IT services and data purchase agreements.
- Demonstrated experience 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.
Benefits
- Health insurance
- Insurance benefits
- 401(k) matching contribution
- Short-term incentive opportunity
- Performance-based award
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.