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Job Category:Legal Work Location: Celgene Summit 86 Morris Avenue Summit 07901 Schedule:Full-time Shift: Day Job Employee Status: Regular Job Type: Standard Job Level: Executive Travel: No
Description Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsibilities will include, but are not limited to, the following:
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 Celgene’s 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.
J.D. 7+ years of legal experience with a pharmaceutical company, healthcare-related law firm and/or regulatory agency required.
Admitted to the N.J. State Bar or eligible to obtain a N.J. limited licenseforin-housecounsel.
Minimum of 7 years of legal experience with a pharmaceutical company, healthcare-related law firm and/or regulatory agency.
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 relations including being a team player and building collaborative, effective relationships within the Law Department and with other functions.
Demonstrated experience in thinking critically to identify and 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 skills (both verbal and written); strong leadership skills.
Experience with digital and social media policies, regulations, guidance and industry practice.
Background in neuroscience products preferred but not required.
Experience drafting and reviewing written compliance policies and SOPs.
Admission to the N.J. State Bar or eligible to obtain a N.J. limited license for in-house counsel.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.