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Senior Director, Franchise Counsel - Hematology / Oncology
Refer job# CFOY137645
Senior Director, Franchise Counsel - Hematology / Oncology 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 Company 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 Celgene 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. Should 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. Demonstrated experience in thinking critically to identify and analyze complex, novel, and challenging issues and timely providing compliant, practical, creative and implementable solutions are essential. Excellent communication skills (both verbal and written); strong leadership skills are essential. Experience with digital and social media policies, regulations, guidance and industry practice is needed. Background in hematology or oncology products is preferred. Experience drafting and reviewing written compliance policies and SOPs is essential. Admission to the NJ state Bar or eligible to obtain.

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