Legal Counsel – Branded and Biologic Products

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 October 2024, Meitheal, directly or through its partners, has 18 products in the research and development phase, 6 additional products planned for launch in 2024, and 21 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.

Learn more about who we are and what we do at www.meithealpharma.com.

Position Summary:

The Legal Counsel – Branded and Biologic Products is responsible for providing comprehensive legal support across a variety of commercial, regulatory, operational, and intellectual property matters related to the Company’s branded and biologic product portfolio. Reporting to the General Counsel, this role serves as a key legal advisor to the business, ensuring compliance with healthcare laws while driving innovative market access strategies and supporting the Company’s intellectual property and promotional review initiatives.

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 ample opportunities for professional development and career advancement.

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

Legal Counseling:

• Provide pragmatic, solutions-oriented legal counsel on payer and distribution contracting strategies for existing and newly launched branded and biologic products.
• Counsel on compliance and risk mitigation for market access initiatives, including copay programs, discount strategies, and payer customer disputes.

Contract Drafting & Negotiation:

• Draft, review, and negotiate agreements, including PBM, GPO, specialty pharmacy, wholesaler, discount/rebate, distribution, value-based, vendor, and service agreements.
• Support the development and expansion of patient support programs across the branded and biologic product portfolio from a legal and compliance perspective.

Regulatory Guidance:

• Advise on compliance with laws and regulations, including Medicare Parts B and D, 340b, Medicaid, Veterans Health Care Act, and      state-specific drug pricing transparency laws.
• Ensure compliance with the Anti-Kickback Statute, Fraud and Abuse, PhRMA Code, OIG guidance, and other U.S. healthcare regulations.

Intellectual Property Management:

• Manage the Company’s intellectual property portfolio for branded and biosimilar products, collaborating with internal and external stakeholders to protect and maximize asset value.

Promotional Review and Training:

• Lead the advertising and promotional review (Ad/Prom) process for branded and biosimilar products, ensuring materials comply with applicable laws and regulations.
• Participate in the training and Medical-Legal-Regulatory (MLR) review process to support cross-functional teams in navigating compliance requirements.

Cross-Functional Collaboration:

• Partner with business leaders and legal department colleagues to deliver aligned legal and regulatory guidance.
• Develop and deliver training programs to educate internal teams on legal requirements and Company policies.

Policy Development and Compliance Monitoring:

• Analyze policy and regulatory developments, such as the Inflation Reduction Act, to guide business strategies.
• Draft and review standard operating procedures (SOPs) and policies to ensure alignment with legal requirements.
• Support compliance-related initiatives, including advisory boards, patient support programs, and access strategies.
• Conduct periodic risk assessments and audits to evaluate adherence to applicable laws.

Competencies

• Business Acumen
• Critical Thinking & Analytical Skills
• Communication & Negotiation Expertise
• Team Collaboration & Conflict Resolution
• Proactive Problem-Solving

Qualifications

Required:

• JD from an ABA-accredited law school and membership in a state bar.
• Minimum of 10 years of post-JD experience in life sciences, either in-house or at a law firm.
• Expertise in healthcare laws applicable to market access activities, including Medicaid, 340B, and anti-kickback statutes.
• Advanced drafting and negotiating skills with exceptional attention to detail.
• Demonstrated ability to manage multiple projects and prioritize effectively in a fast-paced environment.

Preferred:

• In-house pharmaceutical or biotechnology legal experience.
• Knowledge of branded and biologic products, FDA regulations, and market access strategies.
• Experience with compliance programs, patient support initiatives, and value-based contracting.
• Familiarity with intellectual property management and promotional review processes.

Travel

• Occasional domestic travel required (up to 5%).

Computer skills

• Proficient in Microsoft Word, PowerPoint, and Excel.

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.