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Food & Drug Administration Attorney in Roseland, NJ

Lowenstein Sandler LLP Nov 08,2017 Aug 10,2017 Location USA Roseland NJ
This job is expired...

Law Firm

Attorney

Litigation - Regulatory Enforcement (SEC, Telecom, Energy, etc.)

Min 7 yrs required

Profile

Counsel - Life Sciences Group The candidate will advise clients on FDA regulatory and fraud and abuse compliance issues related to pre-approval product communications, interactions with payors/managed markets, advertising and promotion, interactions with healthcare professionals, and sample accountability; serve on internal company committees including compliance and promotional review; draft compliance policies and procedures; and conduct client training on the laws and regulations governing the sales and marketing of regulated products. Will negotiate/draft commercial agreements for various customer segments including specialty pharmacies, pharmacy benefit managers, group purchasing organizations, wholesalers, integrated delivery networks, distributors, third-party logistics providers and master service agreements for all commercial aspects of the business. Assist clients in establishing global clinical development programs; negotiate and draft the various agreements relevant to a clinical development program, including development and formulation; contract research organizations; clinical trial sites; laboratory services; manufacturing; packaging; drug storage and shipment; meeting logistics; and other necessary vendor agreements. Assist with healthcare compliance and clinical trial related investigations. Train and manage junior attorneys.

Qualification and Experience

The candidate must be a senior attorney with 7+ years of experience in the life sciences industry advising pharmaceutical and biotech companies from clinical development through commercialization for prescription drugs, biologics and medical devices. Required experience includes knowledge of FDA laws and regulations governing pre-clinical and clinical development, as well as familiarity with European Union requirements. Knowledge of federal and state transparency and aggregate spend laws is needed. Experience as in-house counsel in the life sciences industry is preferred.

Note: Flexible work arrangements can be considered.

Company info