Our client, a publicly traded specialty pharmaceutical company in Northern New Jersey, is seeking an attorney with a minimum of 4-7 years experience for the position of Associate Director, Corporate Counsel. This position provides legal expertise and support across all business functions within the Company. The position will need to frequently interact with senior level staff, as well as other constituents within the Company and externally to ensure complete alignment with respect to contract development, approval and execution. In addition, this position will assist with various projects, litigations, and investigations as needed.
- Manage the contracting function for various departments within the Company;
- Draft contracts and provide substantive legal review of third-party contracts;
- Partner with business departments within the Company, including but not limited to Commercial, Marketing, Medical, Clinical, Business Development, Supply Operations and Research and Development regarding the drafting and negotiation of all agreements;
- Draft, review and negotiate Healthcare Professional (HCP) Consulting Agreements and Clinical Trial Agreements;
- Potentially supervise and direct activities of Paralegal(s) to ensure efficient and accurate operations;
- Advise all business departments within the Company regarding FDA regulatory matters and compliance with laws, regulations, industry standards and Company policies that may arise throughout the Product lifecycle;
- Provide legal counsel on health care laws, including the Federal Anti-Kickback Statute, False Claims Act and related health care legal obligations;
- Provide legal advice and business counsel on innovative marketing and sales strategies, activities and programs;
- Working closely with other Legal Department colleagues and Compliance professionals to provide consistent and efficient legal and compliance support to the Company in accordance with the Company’s healthcare compliance policies and related laws, codes and regulations;
- Work closely with cross-functional teams supporting the business, including Clinical, Medical Affairs, Regulatory, Compliance, Finance, Procurement, Tax and other business functions to facilitate consistent and efficient support for clinical trials; and
- Other ad hoc analysis / projects as deemed appropriate.
- Juris Doctorate degree from Accredited Law School is required.
- Admission to the N.J. State Bar or eligible to obtain a N.J. limited license for in-house counsel.
- Minimum of 4-7 years of major law firm or in-house experience representing pharmaceutical and/or biotech companies.
- Demonstrated understanding of the U.S. and E.U. Legal requirements related to the pharmaceutical industry.
- Strong grasp of 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, clinical trials, etc.
- Knowledge of enforcement landscape, including relevant industry investigations, litigation and settlements.
- Experience drafting and negotiating contracts such as master service agreements, statements of work, confidentiality agreements, supply agreements, consulting agreements, clinical trial and related agreements, and other corporate pharmaceutical-related agreements is required.
- Must understand contract law and have strong communication and negotiation skills and the ability to influence and work collaboratively at all levels and across functions.
- Proven ability to interpret and apply legal requirements to specific projects and agreements.
- Proven knowledge of corporate legal issues, particular to the pharmaceutical and/or biotech industry including contracts.
- Excellent written and verbal English communication skills.
- Demonstrated excellent organizational skills.
- Proven negotiation skills.
- Proven ability to manage multiple projects, set priorities and meet deadlines.
Salary commensurate with experience. Bonus and equity eligible position.Submit Resume