Associate General Counsel - R&D Innovation Legal, Regulatory
Associate General Counsel - R&D Innovation Legal, Regulatory
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Salary Not Disclosed
1 Vacancy
Job Description
As an Associate General Counsel in the R&D Innovation Legal group you will support AbbVies R&D organization in navigating enterprisecritical 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 businessoriented approach and provide expert counsel on decisions impacting our longterm pipeline strategies.
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.
- Provides legal support to Regulatory Affairs on critical and strategic regulatory filings and agency engagements relating to R&D issues impacting our investigational and onmarket drug products.
- 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.
Qualifications :
- Juris Doctorate 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 inhouse at a pharmaceutical company or practicing as an attorney for the FDA or any combination of the above.
- Individual will have substantial expertise in FDA regulations and guidance around innovator drug development including on clinical trial design and study requirements regulatory exclusivities orphan drug designations 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 and 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 crossfunctional 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 located proximately to North Chicago IL or in the Washington DC metro area as this is a hybrid opportunity.
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 posting based 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 or less 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 commission incentive 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 paid and 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:
No
Employment Type :
Fulltime
Employment Type
Full-time
