Associate Director, Corporate Counsel

Amneal Pharmaceuticals LLC; Bridgewater Township (NJ); On-site; USD 140,000 - 180,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Bridgewater, NJ seeks a Commercial Counsel to serve as a trusted advisor for commercial activities involving specialty, biosimilar and generic products, and to participate in PARC. You will draft, negotiate and review general contracts and market access agreements while guiding teams on regulatory compliance and promotional review.

The role requires advising on FDCA, anti-kickback, FCA, FDA regulations, HIPAA/privacy, and related state laws; you will collaborate

Qualifications

• Must hold a JD and bar admission.
• Experience in pharma/biotech regulatory and commercial contracting preferred.
• Strong knowledge of US pharmaceutical laws and regulatory frameworks.

Responsibilities

• Advise on promotional and commercial activities for specialty, biosimilar and generic products.
• Draft, review and negotiate contracts including HCP consultant agreements, MSAs and SOWs.
• Counsel on FDCA, anti-kickback statutes, FCA, FCPA, FDA regulations, OIG guidance and HIPAA/privacy.
• Provide guidance on market access and customer-facing contracting strategies.

Skills

Contract drafting

Negotiation

Regulatory compliance

FDA knowledge

Cross-functional collaboration

Education

Juris Doctor (JD)

Tools

Legal research databases

MS Office

Job description

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.