BioSpace
Associate General Counsel - R&D Innovation Legal (Regulatory)
BioSpace, North Chicago, Illinois, us, 60086
Overview
Associate General Counsel - R&D Innovation Legal (Regulatory) Join to apply for the
Associate General Counsel - R&D Innovation Legal (Regulatory)
role at
BioSpace As an Associate General Counsel in the R&D Innovation Legal group, you will support AbbViefers 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 role requires a strategic, business-oriented approach and the ability to provide expert counsel on decisions impacting long-term pipeline strategies. Location: North Chicago, IL or Washington, DC metro area (hybrid). This is a hybrid opportunity and relocation considerations may apply. 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. Provide legal support to Regulatory Affairs on critical and strategic regulatory filings and agency engagements relating to R&D issues impacting investigational and on-market drug products. 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 resolution. 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 an expert in the 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 partner in a national law firm life sciences practice, in-house at a pharmaceutical company, or as an attorney for the FDA, or any combination of the above. Substantial expertise in FDA regulations and guidance around innovator drug development, including clinical trial design and study requirements, regulatory exclusivities, orphan drug designations, and combination products; familiarity with policies to advance innovation in the industry. Experience working for, or interacting 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. Proximity to North Chicago, IL or Washington, DC metro area required due to hybrid work arrangement. 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. Individual compensation paid within this range will depend on many factors including geographic location and may be more or less than the posted range. This range may be modified in the future. Salary: $177,000 - $336,000 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 short-term incentive programs. This job is eligible to participate in long-term incentive programs. 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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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Associate General Counsel - R&D Innovation Legal (Regulatory) Join to apply for the
Associate General Counsel - R&D Innovation Legal (Regulatory)
role at
BioSpace As an Associate General Counsel in the R&D Innovation Legal group, you will support AbbViefers 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 role requires a strategic, business-oriented approach and the ability to provide expert counsel on decisions impacting long-term pipeline strategies. Location: North Chicago, IL or Washington, DC metro area (hybrid). This is a hybrid opportunity and relocation considerations may apply. 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. Provide legal support to Regulatory Affairs on critical and strategic regulatory filings and agency engagements relating to R&D issues impacting investigational and on-market drug products. 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 resolution. 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 an expert in the 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 partner in a national law firm life sciences practice, in-house at a pharmaceutical company, or as an attorney for the FDA, or any combination of the above. Substantial expertise in FDA regulations and guidance around innovator drug development, including clinical trial design and study requirements, regulatory exclusivities, orphan drug designations, and combination products; familiarity with policies to advance innovation in the industry. Experience working for, or interacting 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. Proximity to North Chicago, IL or Washington, DC metro area required due to hybrid work arrangement. 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. Individual compensation paid within this range will depend on many factors including geographic location and may be more or less than the posted range. This range may be modified in the future. Salary: $177,000 - $336,000 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 short-term incentive programs. This job is eligible to participate in long-term incentive programs. 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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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