Associate General Counsel, R&D Innovation Legal

Posted 5 Days Ago
Be an Early Applicant
North Chicago, IL, USA
Hybrid
182K-346K Annually
Expert/Leader
Healthtech • Pharmaceutical
The Role
Advise AbbVie's R&D and Regulatory Affairs on FDA regulatory and drug-development matters, including regulatory filings, agency engagements, exclusivities, orphan drug designations, clinical trial design, combination products, and innovation-related policies. Provide strategic counsel to senior leaders, identify and resolve complex legal issues, educate stakeholders, lead cross-functional teams, and support long-term pipeline strategy. Onsite presence required three days per week in North Chicago or Washington, DC.
Summary Generated by Built In
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. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 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, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s 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 https://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

Skills Required

  • J.D. and currently admitted to the bar in at least one U.S. state
  • Minimum of 10+ years relevant legal experience (12+ preferred) at a law firm, in-house at a pharmaceutical company, or at the FDA
  • Substantial expertise in FDA regulations and guidance related to innovator drug development, regulatory exclusivities, orphan drug designations, clinical trial design and data requirements, and combination products
  • Experience providing strategic counsel to senior leaders within the pharmaceutical industry
  • Demonstrated ability to work independently and lead cross-functional teams
  • Excellent oral and written communication skills; comfortable presenting complex information to senior leaders
  • Ability to be in the office 3 days/week at North Chicago, IL or the Washington, DC metro area
  • Experience working for, or interacting with, government health authorities
  • Familiarity with the Inflation Reduction Act, Most Favored Nation and CMS policies and their impact on drug development strategies

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
  • Parental & Family Support Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
  • Healthcare Strength Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.

AbbVie Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: North Chicago, IL
50,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

Similar Jobs

Webflow Logo Webflow

Sales Development Representative

Artificial Intelligence • Enterprise Web • Software • Design • Generative AI
Easy Apply
Hybrid
Chicago, IL, USA
800 Employees
90K-90K Annually

Samsara Logo Samsara

Senior Software Engineer

Artificial Intelligence • Cloud • Computer Vision • Hardware • Internet of Things • Software
Easy Apply
Remote or Hybrid
United States
4000 Employees
114K-191K Annually

Adyen Logo Adyen

Program Manager

Fintech • Payments • Financial Services
Easy Apply
Hybrid
Chicago, IL, USA
4771 Employees
110K-145K Annually

Pfizer Logo Pfizer

Sr. Manager, Optimizations - HCP Products & Experiences

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
In-Office or Remote
3 Locations
121990 Employees
124K-207K Annually

Similar Companies Hiring

Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Mobile • Insurance • Healthtech • Financial Services • Artificial Intelligence
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account