Associate General Counsel, R&D Innovation Legal

## Company Description **About AbbVie** AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](http://www.abbvie.com/). Follow @abbvie on [LinkedIn,](https://www.linkedin.com/company/abbvie/) [Facebook](https://www.facebook.com/AbbVieGlobal/), [Instagram](https://www.instagram.com/abbvie/), [X](https://twitter.com/abbvie) and [YouTube.](https://www.youtube.com/user/AbbVie) ## Job Description As an Associate General Counsel in the R&D Innovation Legal group, you will support AbbVie’s R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. This individual will be motivated by the opportunity to address and solve emerging issues with a strategic and creative business-oriented approach and provide expert counsel on decisions impacting our long-term pipeline strategies. **Key Responsibilities** Develop and provide strategic counsel to senior leaders within the Legal and Regulatory Strategy organizations on legal regulatory issues that impact pipeline development and product innovation. Assigned matters have significant impact to AbbVie overall. **This is a role advising the R&D organization and not on FDA promotional considerations or advising the Commercial organization**. Provides 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. Educates other AbbVie legal departments and business stakeholders on emerging laws, regulations and industry trends impacting AbbVie portfolio. Proactively identifies highly complex legal issues related to assigned matters, develops creative and alternative solutions, and implements resolution. Adopts a business oriented and creative approach to problem solving. Identifies unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company. Advises Vice Presidents, Presidents and Officers. Recognized by these clients as both expert in substantive area and relied upon for individual advice. **To be successful in this role**: - You offer specialized FDA regulatory and drug development experience. You have demonstrated success in providing strategic counsel to leaders within the pharmaceutical industry. ## 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). - Individual will have substantial e**xpertise 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 have familiarity with policies to advance innovation in the industry. - Experience working for, or having interactions with, government health authorities is highly desirable. - 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 as…