Princeton Legal Search Group has been retained on an exclusive basis by a global pharmaceutical company seeking an experienced attorney for the position of Assistant General Counsel. This position will serve as an integral member of the in-house legal team and will report to the General Counsel. The Company will offer competitive compensation and benefits for this position. The Company is located in New Jersey and offers remote work flexibility with 2-3 days in the office per week. Initially, the position will be fully remote.
In this role, you will provide a broad array of legal services, working directly with both the business and other members of the Legal Department in a fast-paced environment that will further develop your capabilities as a lawyer, your business judgment, and your leadership abilities. The Assistant General Counsel will provide general legal, corporate, commercial, regulatory, and compliance support relating to the Company’s transactional, product development, regulatory, and compliance activities. This position requires excellent written and oral communications skills, and the ability to work with all departments across the Company, affiliated/parent companies, domestic and international partners, outside counsel, and licensing and regulatory authorities.
The ideal candidate will have experience in a broad range of areas concerning pharmaceuticals, including transactional matters (drafting and negotiating corporate and commercial contracts), compliance (including experience with the Anti-Kickback Statute and False Claims Act), FDA regulatory matters, Hatch-Waxman Act matters, international trade, product due diligence (including the ability to collaborate with IP counsel regarding patent analyses), and general corporate governance. FDA expertise is not required but there is an expectation that you will develop an understanding of FDA regulatory matters.
Must be independent, analytical, able to effectively communicate across departments, and have the ability to prioritize work in a fast-paced, deadline-driven environment.
DUTIES AND RESPONSIBILITIES
- Assist the General Counsel in management of the Legal Department.
- Draft, review and negotiate complex corporate and commercial agreements, including those for purchase, sale, supply, non-disclosure, licensing, joint development, research and development, manufacturing, distribution, services, quality, pharmacovigilance, and M&A transactions.
- Develop and implement contract strategies, processes, and controls in conjunction with other members of the Legal Department.
- Conduct legal due diligence for product development and M&A transactions.
- Analyze existing agreements and counsel the business regarding the Company’s rights and obligations.
- Monitor and report on legal and regulatory developments, with a focus on laws and regulations applicable to the pharmaceutical industry.
- Assist in the development and drafting of corporate policies and procedures, and provide related compliance training.
- Collaborate with IP counsel to (1) develop and implement IP strategies for product development and (2) advise the business regarding the strength of potential IP challenges prior to initiating product development.
- Collaborate with other members of the Legal Department and the business to achieve the Company’s goals.
ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE
- JD degree from accredited U.S. law school (or the equivalent).
- Admission to the Bar of a U.S. state or the District of Columbia.
- 10+ years of corporate, commercial and IP transactional experience including in-and-out licensing (preferably concerning the pharmaceutical industry), together with experience in regulatory and compliance matters applicable to the U.S. pharmaceutical industry.
- Knowledge of the Hatch-Waxman Act would be a plus.
- Prior in house experience is preferred.