Associate General Counsel, R&D Innovation Legal

About the role

The Associate General Counsel in the R&D Innovation Legal group supports AbbVie’s R&D organization in navigating legal and regulatory issues that impact pipeline development and product innovation. This role advises the R&D organization rather than the Commercial organization.

Responsibilities

• Develop and provide strategic counsel to senior leaders within the Legal and Regulatory Strategy organizations on legal and regulatory issues impacting pipeline development and product innovation.
• Provide legal support to Regulatory Affairs on critical and strategic regulatory filings and agency engagements relating to R&D issues impacting our investigational and on-market drug products.
• Willing to develop an understanding of the Inflation Reduction Act and other “Most Favored Nation” policies to provide strategic counsel to the R&D organization.
• Educate other AbbVie legal departments and business stakeholders on emerging laws, regulations, and industry trends impacting AbbVie portfolio.
• Proactively identify highly complex legal issues related to assigned matters, develop creative and alternative solutions, and implement resolutions.
• Adopt a business-oriented and creative approach to problem-solving. Identify unmet needs and future legal issues and proactively propose strategies to optimize outcomes and results for the company.
• Advise Vice Presidents, Presidents, and Officers. Recognized by these clients as both expert in substantive area and relied upon for individual advice.

Qualifications

• J.D. and currently admitted to the bar in at least one U.S. state.
• Minimum of 10+ years (12+ preferred) of relevant experience practicing as a member of a nationally recognized law firm in a life sciences practice, practicing in-house at a pharmaceutical company, or practicing as an attorney for the FDA, or any combination of the above (experience working in-house or at FDA is preferred).
• Demonstrated success in providing strategic counsel to leaders within the pharmaceutical industry.
• Substantial expertise in FDA regulations and guidance around innovator drug development, including on regulatory exclusivities, orphan drug designations, clinical trial design and data requirements, and combination products, and familiarity with policies to advance innovation in the industry.
• Familiarity with the Inflation Reduction Act, Most Favored Nation, and CMS policies and their impact on drug development strategies is a plus.
• Knowledge and understanding of pharmaceutical laws and regulations to help business clients assess issues in a highly regulated landscape.
• Demonstrated ability to work independently and lead cross-functional teams collaboratively.
• Excellent oral and written communication skills. Comfortable presenting complicated information accurately and concisely to senior leaders.

Additional Information

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.