Other Locations:US- NJ- Summit East
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.
- 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.
- Minimum of 7 years of legal experience, inclusive of 5 years of legal experience in 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, 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.
- History of self-motivation, sound judgment and excellent interpersonal relations including being a team player and building collaborative, effective relationships within a legal department and with other functions/stakeholders.
- 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 a 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 hematology or oncology 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.