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Senior Corporate Counsel
Refer job# HGYW149038
 
Senior Corporate Counsel The candidate will be reviewing advertising, promotional, training, disease awareness and similar materials for the companys pharmaceutical products, as well as provide counsel and contracting to the business regarding its commercial activities in accordance with applicable laws and regulations. Will be providing legal support to trade, managed markets and the Companys patient hub services on a broad range of market access and other healthcare law issues, such as trade and payor relationships, pricing and patient support programs, and managed markets contracting needs. Represent the legal department within the promotional review committee for the Company brand teams, providing strategic recommendations and guidance on compliance with applicable laws and FDA regulations for appropriate sales and marketing of pharmaceutical products. Represent the legal department within the medical review teams for medical affairs, providing guidance on compliance with applicable laws and FDA regulations for appropriate scientific exchange for approved and investigational products. Demonstrate knowledge of FDA labeling requirements for the promotion of prescription drugs, with the ability to successfully apply this knowledge. Maintain an awareness of enforcement trends in the pharmaceutical industry. Advise the business on commercial activities to ensure compliance with company policies, the PhRMA code, applicable laws and regulations including the False Claims Act, Privacy Laws, and Anti-kickback Laws. Participate in brand team meetings to keep informed of commercial activities and ensure that Company strategies, programs, policies and initiatives comply with laws. Provide strategic advice and counsel on legal, regulatory and compliance issues related to payor relationships, distribution, coverage and reimbursement, product pricing and government pricing, and patient support programs. Draft, negotiate and amend various commercial contracts, including, distribution agreements, manufacturing agreements, NDAs, master service agreements and statements of work, consulting agreements, and data purchase agreements. Provide privacy counseling related to patient support programs. Interact with cross functional departments, outside counsel, regulatory authorities and vendors as needed. Mentor and supervise junior attorneys. Must have JD degree. Licensed to practice law in a US state, and either in good standing in New Jersey or able to obtain a NJ limited license for in-house counsel is essential. Should have 5-10 years of experience in a legal department, pharmaceutical corporation, law firm or related government agency setting. Experience serving on medical and promotional review committees, and proficiency with VEEVA, highly desired/. Experience directly related to the legal market access duties and responsibilities specified. Proficient in Microsoft office (primarily Word, PowerPoint and Excel) is needed.
 
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