Description:

Job Description:
As an Associate General Counsel in the R&D Innovation Legal group, you will support An American Publicly Traded Biopharmaceutical Company'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.

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 An American Publicly Traded Biopharmaceutical Company 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 on-market drug products.
Educates other An American Publicly Traded Biopharmaceutical Company legal departments and business stakeholders on emerging laws, regulations and industry trends impacting An American Publicly Traded Biopharmaceutical Company 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 in-house 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 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 located proximately to North Chicago, IL or in the Washington, DC metro area as this is a hybrid opportunity.