Vice President of Legal, Specialty Products Division

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good.

Position Summary:

The Vice President of Legal for the Specialty Products Division will be a key strategic and hands-on legal partner, providing critical counsel on compliance with federal price reporting requirements, regulatory matters, and legal support for market access and pricing functions. As this is a newly created division, this role requires a roll-up-your-sleeves approach, directly handling legal responsibilities while helping to shape the department's needs as the business scales. While there are no current direct reports, there is potential for team expansion as the division grows. This role will involve advising senior management on complex legal issues related to product pricing, market access, and regulatory compliance, as well as drafting, reviewing, and negotiating key agreements. The Vice President of Legal will play a pivotal role in ensuring the division's adherence to legal and regulatory standards while supporting its mission to bring specialty products to market efficiently and compliantly.

Payrate is determined by considering a person's prior experience and competence.

Why Work with Us?

* Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

* Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

* Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

* Professional Growth: We offer many opportunities for professional development and career advancement.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Oversee legal compliance with federal price reporting requirements (e.g., AMP, Best Price, ASP, 340B) and provide guidance on related regulatory issues.
• Ensure compliance with federal healthcare program contracting, including Medicaid, Medicare, and VA/DoD agreements.
• Manage and oversee the Medical, Legal, and Regulatory (MLR) Review Process, ensuring promotional, advertising, and educational materials comply with FDA regulations (including OPDP guidance), FTC laws, and industry standards.
• Review and approve advertising, marketing, and promotional materials, collaborating with regulatory, medical, and marketing teams to ensure product claims and strategies align with legal and compliance requirements.
• Provide expert legal advice on compliance with the Anti-Kickback Statute, False Claims Act, competition laws, and other pricing-related regulations.
• Support pricing and market access strategies to ensure compliance with state and federal laws governing rebates, discounts, and government payor programs.
• Advise on FDA regulatory matters, including product labeling, promotional activities, and biologics-specific compliance requirements (e.g., BPCIA).
• Manage and provide legal oversight of intellectual property (IP) portfolios for Specialty Products, including patents, trademarks, exclusivity protections, and licensing agreements.
• Stay abreast of legal and regulatory changes affecting the pharmaceutical and biologics industries, providing proactive guidance on policy and procedural adjustments.
• Prepare, review, and negotiate complex agreements with government entities, payors, trade partners, and third-party vendors, ensuring alignment with regulatory frameworks and company objectives.
• Draft and negotiate contracts related to clinical trials, research collaborations, and biologic manufacturing, with attention to intellectual property and exclusivity issues.
• Collaborate with senior management, compliance, and commercial teams to address legal risks and opportunities related to product development, commercialization, and market access.
• Demonstrated management experience, with the ability to lead and develop a legal team as the division scales. While this is a hands-on role with no current direct reports, the ability to mentor, guide, and manage future legal team members will be key to long-term success.
• Develop and implement internal policies to ensure ongoing compliance with legal and regulatory requirements.
• Serve as a key legal advisor to senior management, offering strategic guidance on legal and compliance risks in support of the company's business goals.
• Lead high-visibility legal projects and provide practical solutions to complex regulatory challenges in a dynamic, matrixed environment.

Supervisory

* None, Currently

Competencies

* Business Acumen

* Judgement

* Change Management

* Project Management

* Ethics

* Interpersonal

Qualifications

* In-depth knowledge of federal price reporting requirements (e.g., AMP, Best Price, ASP, 340B) and federal healthcare program contracting.

* Strong proficiency in legal and regulatory compliance, particularly within the pharmaceutical industry.

* Proven ability to manage high-visibility projects and communicate effectively with senior leadership.

* Demonstrated skill in providing practical legal solutions to complex issues in a dynamic, matrixed environment.

* Ability to work independently while managing multiple priorities and tight deadlines.

* Juris Doctor (JD) degree from an ABA-accredited law school and licensed to practice law in the relevant state, or ability to gain licensure.

* Minimum of 15 years of relevant legal experience, with a strong legal background in the branded and or biosimilars industry, including market access and compliance.

* Proficiency in compliance matters related to federal price reporting and healthcare program contracting.

* Experience in negotiating and drafting complex agreements, with a clear understanding of regulatory frameworks impacting specialty products.

Travel

Up to 10% travel may be required to support division activities and interact with stakeholders as necessary.

Computer skills

* Proficiency in general Microsoft Office applications (Word, Excel, PowerPoint).

* Familiarity with legal research tools and software.

Equal Opportunity Employer:

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.