Senior Counsel, Specialty Commercial & Market Access

Job Type

Full-time

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 from initial business consultation through resolution and implementation.
• Develop strong relationships with business leaders and serve as a trusted legal advisor who provides timely, practical and commercially informed recommendations.
• Proactively identify legal risks, emerging issues and opportunities to improve business practices rather than responding solely to individual requests.
• Develop and improve contract templates, legal guidance, policies and procedures relevant to assigned business functions.
• Manage outside counsel on assigned matters, including work allocation, budgets and quality of advice.
• Collaborate with other Legal team members, sharing specialized knowledge and supporting consistent legal practices across the organization.
• Provide training and guidance to business stakeholders on relevant commercial, regulatory and legal requirements.
• Support other legal projects and initiatives as assigned by the General Counsel.

Competencies

• Business Acumen.
• Independent Judgment and Accountability.
• Pharmaceutical Commercial and Regulatory Expertise.
• Strategic Thinking and Proactive Problem-Solving.
• Executive Communication and Influence.
• Contract Drafting and Negotiation.
• Cross-Functional Collaboration.
• Adaptability and Continuous Improvement.
• Project and Matter Management.
• Integrity and Professional Judgment.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Required

• Demonstrated experience supporting pharmaceutical market access, pricing, reimbursement and commercial contracting.
• Strong working knowledge of healthcare fraud-and-abuse laws, government pricing requirements and legal issues affecting pharmaceutical commercialization.
• Experience advising on FDA prescription drug advertising and promotion requirements and participating in promotional or MLR review.
• Proven ability to independently draft and negotiate complex pharmaceutical commercial agreements.
• Excellent judgment, communication and negotiation skills, with the ability to provide practical recommendations to senior business stakeholders.
• Ability to manage multiple priorities, meet deadlines and work independently in a fast-paced, highly regulated environment.

Preferred

• Experience supporting branded, specialty pharmaceutical or biosimilar products.
• Experience with payor, PBM, GPO, specialty pharmacy and distribution agreements.
• Experience advising patient support programs, launch readiness and product commercialization.
• Experience with pharmaceutical licensing, strategic collaborations or clinical development transactions.
• Prior in-house experience working directly with Commercial, Medical, Regulatory, Finance and Compliance teams.
• Experience improving MLR processes, contracting practices or legal department efficiency.

Education and/or Experience

• Juris Doctor degree from an ABA-accredited law school.
• Active membership in good standing in at least one U.S. state bar and eligibility to practice as in-house counsel in Illinois.
• Minimum of eight (8) years of relevant legal experience, including substantial experience advising pharmaceutical or biotechnology companies.

Travel

• Occasional travel may be required to support business activities and stakeholder meetings.

Computer Skills

Microsoft Word, PowerPoint and Excel.

Salary Description

$215,000 to $250,000 / year