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Global biopharmaceutical company is seeking a Senior Franchise Counsel, Inflammation and Immunology to join its legal team. This position is located in the company’s Northern New Jersey office.
Advising clients on FDA regulatory matters and compliance with laws, regulations, industry standards and company policies that arise throughout the product lifecycle, including in the areas of product development, advertising and promotion, research and quality;
Providing legal counsel on health care laws, including the Federal Anti-Kickback Statute, False Claims Act, and related health care legal obligations;
Providing legal advice and business counsel on innovative marketing and sales strategies, activities and programs, including review of advertising and promotional strategies and materials, and digital and social media initiatives, and working with clients to develop appropriate and compliant strategies for interacting with healthcare providers and other stakeholders;
Providing and coordinating legal support as a member of cross-functional teams supporting the assigned therapeutic area;
Providing legal advice and business counsel to the market access team, including advice on developing and implementing payer strategies and patient support programs; providing legal advice and business counsel to the medical affairs and corporate medical affairs teams, as required;
Supporting the Global and U.S. Corporate Compliance teams in establishing, embedding and enforcing the company’ss healthcare compliance policies and related laws, codes and regulations;
Engaging in initiatives with trade associations and policy teams related to regulatory issues;
Working closely with other Law Department colleagues and compliance professionals to provide consistent and efficient legal and compliance support to the company.
JD and at least 7+ years of legal experience with a pharmaceutical company, healthcare-related law firm and/or regulatory agency;
Admission to the NJ State Bar or eligible to obtain a NJ limited license for in-house counsel;
Expertise in relevant federal and state laws, regulations, rules and guidance as well as industry codes and principles impacting pharmaceutical manufacturers, including but not limited to applicable law concerning drug labeling, advertising, government reimbursement and product liability;
Knowledge of enforcement landscape, including relevant industry litigation, settlements, and corporate integrity agreement obligations;
History of self-motivation, sound judgment and excellent interpersonal skills;
Demonstrated experience in thinking critically to identify/analyze complex novel and challenging issues and timely providing compliant, practical, creative and implementable solutions;
Ability to thrive in fast-paced environment and well-manage a dynamic portfolio of in-line and pipeline products;
Excellent communication (verbal and written) skills; leadership skills;
Experience with digital and social media policies, regulations, guidance and industry practice;
Background in neuroscience products preferred but not required;
Experience drafting/reviewing written compliance policies and SOPs.
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