Senior Counsel, Specialty Commercial & Market Access

Meitheal Pharmaceuticals Inc•Chicago, IL

5d•$215,000 - $250,000•Hybrid

About The Position

The Senior Counsel, Specialty Commercial & Market Access serves as a key legal advisor to Meitheal Pharmaceuticals’ specialty, branded pharmaceutical and biosimilar businesses. The role provides strategic and hands-on legal support across market access, pricing, reimbursement, commercialization, promotional review and related transactions. It partners with Commercial, Market Access, Medical Affairs, Regulatory Affairs, Compliance, Finance, Business Development and other stakeholders to support business objectives while managing legal and regulatory risk. The position serves as the primary legal reviewer for specialty and biosimilar promotional materials through the Medical, Legal and Regulatory (MLR) review process, working with Medical, Regulatory and Compliance colleagues to provide timely, consistent and legally sound review. The Senior Counsel independently manages complex legal matters, anticipates business needs, develops practical solutions and supports the growth of Meitheal’s specialty and biosimilar portfolio.

Requirements

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.
At least eight years of relevant legal experience, including substantial experience advising pharmaceutical or biotechnology companies.
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.
Microsoft Word, PowerPoint and Excel skills.
Ability to travel occasionally to support business activities and stakeholder meetings.

Nice To Haves

Experience supporting branded, specialty pharmaceutical or biosimilar products.
Experience with payor, PBM, GPO, specialty pharmacy and distribution agreements.
Experience advising on 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.

Responsibilities

Advise Specialty Commercial and Market Access on market access strategy, pricing, reimbursement, contracting and distribution.
Draft, review and negotiate agreements with payors, PBMs, 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 on federal and state government pricing requirements, including AMP, Best Price, ASP, Medicaid, Medicare, 340B and VA/Federal Supply Schedule requirements, as applicable.
Advise on the Anti-Kickback Statute, False Claims Act, fraud-and-abuse requirements, competition laws and related risks affecting commercial operations.
Collaborate with Finance, Government Pricing, Compliance and other stakeholders to identify and address pricing and reimbursement issues.
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 MLR procedures.
Evaluate promotional claims and communications for compliance with FDA and FTC requirements, product labeling, advertising and promotional regulations, and relevant legal guidance.
Advise on communications with healthcare professionals, payors and other stakeholders, including scientific exchange, product claims and commercial activities.
Work with Medical Affairs, Regulatory Affairs and Compliance to resolve review comments, identify legal risks and support timely 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 for a consistent and scalable MLR process.
Identify recurring legal issues, regulatory developments and opportunities to improve MLR review efficiency and effectiveness.
Coordinate with Compliance on oversight, monitoring and remediation while retaining accountability for substantive legal review.
Support commercialization planning, launch readiness, lifecycle management and post-launch activities for specialty and biosimilar products.
Advise 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 business responses.
Partner with Regulatory, Medical, Quality and Commercial stakeholders on issues affecting product development and commercialization.
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 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.
Support clinical and research-related agreements within demonstrated expertise, coordinating specialized counsel where appropriate.
Independently manage assigned legal matters from business consultation through resolution and implementation.
Build relationships with business leaders and provide timely, practical and commercially informed recommendations.
Proactively identify legal risks, emerging issues and opportunities to improve business practices.
Develop and improve contract templates, legal guidance, policies and procedures for assigned business functions.
Manage outside counsel on assigned matters, including work allocation, budgets and quality of advice.
Collaborate with Legal team members, share specialized knowledge and support consistent legal practices.
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.