MDWerks Inc.

Senior Counsel, Commercial and Compliance

MDWerks Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $250,000 - $285,000 per year

Job Level

Senior

About the role

  • 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

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

Tip: use these terms in your resume and cover letter to boost ATS matches.

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