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Date Last Verified
Years of Experience
ProfileSenior Corporate Counsel The candidate will be advising clients on FDA regulatory matters and compliance with laws, regulations, industry standards and company policies that arise throughout the product lifecycle. Will be providing legal advice and business counsel on innovative marketing and sales strategies, activities and programs, with a primary focus on review of advertising and promotional strategies and materials, and digital and social media initiatives for products in the Companyâ€™s Hematology-Oncology Franchise. Working with clients to develop appropriate and compliant strategies for interacting with healthcare providers and other stakeholders. Providing legal counsel on health care laws, including the Federal Anti-Kickback Statute, False Claims Act and related health care legal obligations. Providing and coordinating legal support as a member of cross-functional teams supporting the assigned therapeutic area in the Hematology-Oncology Franchise. Supporting the Global and U.S. Corporate Compliance teams in establishing, embedding and enforcing firm's healthcare compliance policies and related laws, codes and regulations. Working closely with other Law Department colleagues and Compliance professionals to provide consistent and efficient legal and compliance support to the Company.
Qualification and Experience
The candidate must have 7 years of legal experience, inclusive of 5 years of legal experience in a pharmaceutical company, healthcare-related law firm and/or regulatory agency. Must have expertise in relevant federal and state laws, regulations, rules and guidance as well as industry codes and principles impacting pharmaceutical manufacturers, focused on drug labeling, drug advertising, fraud and abuse (anti-kickback, off-label promotion), product liability, etc. Knowledge of enforcement landscape, including relevant industry investigations, litigation and settlements is required. Must have demonstrated experience in thinking critically to identify and analyze complex, novel, and challenging issues and timely providing compliant, practical, creative and implementable solutions. Excellent communication skills (both verbal and written); strong leadership skills is required. Experience with digital and social media policies, regulations, guidance and industry practice is required. Background in hematology or oncology products preferred. Must have experience drafting and reviewing written compliance policies and SOPs. Must have Admission to the N.J. Must have Admission to State Bar or eligible to obtain a N.J. limited license for in-house counsel.
Req #: 1800888
86 Morris Avenue
Summit, NJ 07901