Associate Director, Corporate Counsel

Amneal Pharmaceuticals LLC; Bridgewater (MA); On-site; USD 175,000 - 200,000; Full time

Benefits offered by this job

Bonus potential

401(k) matching

Job summary

Amneal Pharmaceuticals LLC invites a Commercial Counsel to join the Legal team in Massachusetts. You will advise on commercial activities across specialty, biosimilar, and generic products and participate in PARC to ensure compliant promotional strategies and materials.

You will draft, review, and negotiate a wide range of contracts, including HCP consultant agreements, vendor SOWs, NDAs, and R&D or IT agreements, while guiding compliance with FDCA and related laws.

Qualifications

• 5+ years of legal experience including in-house pharma/biotech or life sciences law
• Experience reviewing promotional/non-promotional materials and advising on marketing rules
• Experience drafting, reviewing, and negotiating MSAs, NDAs, and vendor/IT agreements

Responsibilities

• Advise on marketing and promotion compliance for pharmaceutical products; participate in PARC to review materials and strategies
• Negotiate, draft, review general commercial contracts including HCP consultant/speaker agreements and supplier/ service agreements
• Counsel on FDCA and related laws/regulations (including anti-kickback, FCA, FCPA, HIPAA)
• Negotiate market access/customer-facing contracts (PBM, GPO, rebates, distribution) and advise on strategy

Skills

Contract negotiation

Regulatory compliance

Legal advice

HCP engagements

Education

Bachelor's degree (BA/BS)

Juris Doctor or equivalent and bar admission

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.

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.

The salary range for this position ranges from $175,000 - $200,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.