Legal And Compliance Counsel Counsel Jobs in New_Jersey - 143611 | Submit Resume | General Counsel Consulting
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Legal And Compliance Counsel
Refer job# ANNN143611
 
Legal and Compliance Counsel The candidate reports directly to the Head, North America Legal and Compliance and is relied on to provide expert, timely legal services to members of the Legal team and the Commercial business. Responsibilities Of Position: Provide research support and advice across a wide range of legal areas; Operate in a highly regulated industry with solid understanding of US Compliance regulations. Advise on various federal and state regulatory requirements such as Federal and State Open Payments regulations, Stark and Anti-Trust regulations, HIPAA, privacy, data protection, and Federal and State Fraud and Abuse laws including the Anti-Kickback Statue, the False Claims Act, and FCPA). Identify, evaluate, and help with compliance issues, applying good judgment and an understanding of business, legal, and regulatory principles related to medical devices and the healthcare industry; Provide advice on marketing programs and contracted services, in view of the highly-regulated nature of the medical device industry; Review and provide assistance to Counsel on various types of contracts, including government contracts, alliance agreements, customer sales agreements, inventory management and managed care agreements, and distribution agreements; Assist Counsel in addressing issues involving legal and compliance matters; efficiently identify issues and make recommendations based, at times, on limited information, and/or in consultation with a supervisor; Assist Counsel in the collection, review and submission of federal and state transparency documentation, and the review and resolution of any potential disputes. Assist Counsel in providing advice on existing and future collaborations and interactions with healthcare providers ( HCPs ) to ensure compliance with US and global laws and regulations, including transparency reporting requirements for such HCP interactions and payment issues. Assist with the development of training documents, in the areas of healthcare compliance and commercial transactions, such as such as anti-corruption, international trade, insider trading, data privacy, HIPAA, and records retention; Assist Counsel in the development and/or review of operating policies and practices; Handle other legal matters as may be assigned by Head of and/or other members of the Legal department.

The candidate Should have Admission to a state bar (with the ability to become licensed as an in-house counsel in NJ, if not otherwise licensed in NJ); (passed the bar exam). Must have 1-3 years of experience as a healthcare Attorney or 3-5 years experience as a Sr. Compliance Paralegal prior to bar admission. Healthcare experience and Compliance experience required. Medical Device experience preferred. Should have ability to prioritize, plan, and organize heavy workloads, while exercising discretion and independent judgment. Must have an understanding of the AdvaMed Code of Ethics. Should preferably have Prior experience successfully operating in a fluid and entrepreneurial environment. Knowledge of FDA and FTC regulations is preferred. Knowledge and experience in review of promotional materials involving medical devices is preferred.
 
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