Senior Counsel, Specialty Commercial & Market Access

Description

ABOUT MEITHEAL PHARMACEUTICALS

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 75 U.S. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of April 2026, Meitheal, directly or through its partners, has 32 products in the research and development phase, 9 products planned for launch in 2026, 4 products in clinical trial phases, and 13 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 regularly as one of Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2026, 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 .

The pay range for this position is $215,000 to $250,000 / year. Payrate is determined by considering a person's prior experience and competence.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

What We Offer

• •Competitive pay and medical, dental, and vision insurance.
• •Flexible spending accounts.
• •Long- and short-term disability insurance, as well as life insurance.
• •401(k) plan with match.
• •Competitive PTO and company-paid holidays.
• •Paid parental leave (maternity & paternity).
• •Employee assistance program.
• •Onsite gym.
• •Hybrid work schedule.

Summary

The Senior Counsel, Specialty Commercial & Market Access will serve as a key legal advisor to Meitheal Pharmaceuticals' growing specialty, branded pharmaceutical and biosimilar businesses, providing strategic and hands-on legal support across market access, pricing, reimbursement, commercialization, promotional review and related transactions. The successful candidate will partner closely with Commercial, Market Access, Medical Affairs, Regulatory Affairs, Compliance, Finance, Business Development and other cross-functional stakeholders to provide practical legal advice that supports business objectives while appropriately managing legal and regulatory risk.

This role will serve as the primary legal reviewer for specialty and biosimilar promotional materials through Meitheal's Medical, Legal and Regulatory (MLR) review process, working collaboratively with Medical, Regulatory and Compliance colleagues to ensure timely, consistent and legally sound review. The position requires an experienced pharmaceutical attorney capable of independently managing complex legal matters, anticipating business needs, developing practical solutions and supporting the continued growth of Meitheal's specialty and biosimilar portfolio.

Essential Responsibilities

Essential Duties and Responsibilities include the following:

Market Access, Pricing and Reimbursement

• •Serve as the primary legal advisor to the Specialty Commercial and Market Access functions on market access strategy, pricing, reimbursement, contracting and distribution.
• •Draft, review and negotiate agreements with payors, pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), wholesalers, distributors, specialty pharmacies, healthcare systems and other commercial partners.
• •Advise on rebate arrangements, discounts, chargebacks, distribution fees, patient access programs and related commercial arrangements.
• •Provide legal guidance concerning federal and state government pricing requirements, including Average Manufacturer Price (AMP), Best Price, Average Sales Price (ASP), Medicaid, Medicare, 340B and VA/Federal Supply Schedule requirements, as applicable.
• •Advise on the Anti-Kickback Statute, False Claims Act, federal and state fraud-and-abuse requirements, competition laws and related legal risks affecting commercial operations.
• •Collaborate with Finance, Government Pricing, Compliance and other stakeholders to identify and address emerging pricing and reimbursement issues.

Medical, Legal and Regulatory (MLR) Review

• •Serve as the primary legal reviewer and designated Legal representative in the MLR process for specialty, branded and biosimilar products, following an appropriate transition of responsibilities.
• •Review and provide legal approval of promotional, advertising, marketing, sales training and educational materials within the scope of the company's MLR procedures.
• •Evaluate proposed promotional claims and communications for compliance with applicable FDA and FTC requirements, product labeling, advertising and promotional regulations, and relevant legal guidance.
• •Advise on appropriate communications with healthcare professionals, payors and other stakeholders, including considerations involving scientific exchange, product claims and commercial activities.
• •Collaborate with Medical Affairs, Regulatory Affairs and Compliance to resolve review comments, identify legal risks and support timely completion of promotional review.
• •Provide legal guidance on complex or novel promotional initiatives, product launches, digital marketing, speaker programs and other commercial communications.
• •Help develop and refine legal review standards, escalation criteria, training and procedures to support a consistent and scalable MLR process.
• •Identify recurring legal issues, regulatory developments and opportunities to improve the efficiency and effectiveness of the review process.
• •Coordinate with Compliance regarding oversight, monitoring and remediation while maintaining clear accountability for substantive legal review.

Specialty and Biosimilar Commercialization

• •Provide legal support for commercialization planning, launch readiness, lifecycle management and post-launch activities for specialty and biosimilar products.
• •Advise cross-functional teams on specialty distribution models, patient support services, reimbursement programs and commercial partnerships.
• •Support legal evaluation of product launch strategies, commercial initiatives and emerging business opportunities.
• •Identify legal and regulatory developments affecting specialty and biosimilar products and recommend appropriate business responses.
• •Partner with Regulatory, Medical, Quality and Commercial stakeholders to address issues affecting product development and commercialization.

Commercial and Strategic Transactions

• •Draft, review and negotiate specialty commercial agreements, including distribution, supply, services, commercialization, collaboration and related contracts.
• •Provide legal support for selected product licensing, business development and strategic partnership initiatives.
• •Support legal due diligence and evaluation of commercial, contractual and regulatory risks associated with potential acquisitions, in-licensing and other business opportunities.
• •Collaborate with internal IP counsel and specialized external counsel on transactions involving intellectual property, biologics, clinical development and manufacturing.
• •Provide legal support for clinical and research-related agreements within demonstrated expertise, coordinating specialized counsel where appropriate.

Legal Department and Business Partnership

Independently manage assigned legal matters