Associate General Counsel, R&D Innovation Legal

As an Associate General Counsel in the R&D Innovation Legal group you will support AbbVies 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 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 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 assess issues in a highly regulated landscape.
• Demonstrated ability to work independently and lead cross-functional teams collaboratively.
• Ability to adapt to a changing environment while handling multiple priorities.
• Excellent oral and written communication skills. Comfortable presenting complicated information accurately and concisely to senior leaders.
• To enable success in the role an individual must be able to be in the office 3 days/week at our offices in North Chicago IL or the Washington DC metro area.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more orless than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

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 commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paidand may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time