Amneal Pharmaceuticals
Commercial Counsel
Amneal Pharmaceuticals, Bridgewater, New Jersey, us, 08807
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.
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.