Senior Counsel, Commercial and Compliance

MDWerks Inc.

Senior Counsel providing legal guidance for commercialization in a biopharmaceutical company. Leading legal support for commercial launches and compliance initiatives.

Posted 4/14/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $250,000 - $285,000 per yearWebsite

About the role

Key responsibilities & impact

Serve as the primary legal advisor to the Commercial and Medical Affairs teams
Provide strategic counsel across pre-launch and launch activities, balancing legal risk with business objectives
Support commercialization readiness, including promotional strategy, market access, patient services, and distribution models
Draft, review, and negotiate a wide range of commercial agreements (e.g., vendors, patient support programs, speaker programs, distribution, market access)
Lead legal review of promotional and medical materials through MLR/PRC processes
Advise on interactions with HCPs, patients, payors, specialty pharmacies, and government entities
Support commercial and medical affairs activities, including speaker programs, advisory boards, sponsorships, grants, medical information requests, and scientific exchange
Provide guidance on compliantly navigating regulatory landscape in business activities such as disease education, HCP engagement, advisory boards, and patient-facing materials
Lead design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance to enable commercialization success
Develop policies, procedures, training, and monitoring frameworks
Implement transparency and aggregate spend reporting processes
Proactively identify legal and compliance risks and develop practical mitigation strategies
Monitor evolving healthcare laws, regulations, and industry trends
Provide clear, business-oriented guidance to senior leadership
Support corporate legal matters and business development initiatives as needed
Manage external counsel effectively
Contribute to building a high-impact, collaborative legal team

Requirements

What you’ll need

J.D. from an accredited law school; active bar membership in at least one U.S. jurisdiction
8–12+ years of legal experience in biotech/pharma (in-house preferred)
Proven experience supporting commercial build and product launch
Deep knowledge of healthcare and compliance laws and regulations (FDA, OIG, PhRMA Code, Anti-Kickback, False Claims Act, Sunshine Act, etc.)
Strong experience with MLR/PRC review, promotional regulations, and compliance program development
Experience drafting and negotiating complex commercial agreements
Ability to operate in a fast-paced, evolving environment with high accountability.

Benefits

Comp & perks

medical
dental
vision
time off
401K
participating in Mineralys incentive plans contingent on achievement of personal and company performance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

J.D.legal experiencecommercial agreementsMLR/PRC reviewcompliance program developmentregulatory compliancepromotional strategymarket accesspatient servicesdisease education

Soft Skills

strategic counselcollaborationrisk mitigationclear communicationleadershipadaptabilityaccountabilityguidanceteam buildingproblem-solving

Certifications

active bar membership