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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in legal counsel for promotional activities, ensuring compliance with FDA and FTC regulations, and possesses strong negotiation and drafting skills for market access agreements. Proficient in collaborating with cross-functional teams to develop compliant promotional strategies and internal policies.
Highest-signal resume keywords
Legal Experience In Pharmaceutical IndustryRegulatory Compliance ExpertiseNegotiation And Drafting SkillsKnowledge Of Market Access RegulationsActive Law License
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Requirements UnderstandingDrafting AgreementsNegotiating ContractsMarket Access Legal GuidancePromotional Review Compliance
Soft Skills
Excellent Communication SkillsProactive MindsetSolution-Oriented ApproachAbility To Manage Multiple Priorities
Certifications & Qualifications
Active Admission To Practice Law
Industry Keywords
FDA RegulationsFTC RegulationsAnti-Kickback StatutesFalse Claims ActPhRMA CodeMedicaid Best PriceAverage Manufacturer Price340B Requirements
About the role
Key responsibilities & impact- Serve as legal counsel on promotional review committees, advising on HCP and consumer-facing materials.
- Lead and participate in MLR (Medical, Legal & Regulatory) reviews to ensure promotional content complies with FDA, FTC and other applicable regulations.
- Work closely with cross-functional teams, including marketing, regulatory affairs, and compliance, to develop compliant and effective promotional strategies.
- Assist in the development and delivery of internal policies and training programs related to promotional activities.
- Drafting, reviewing, negotiating, and advising on a broad range of market access-related agreements, including PBM, payer, GPO, wholesaler, specialty pharmacy, distribution, rebate, discount, value-based, outcomes-based, consulting, advisory board, master services, and data-sharing agreements.
- Collaborating with commercial, medical, regulatory, compliance, finance, and market access teams to ensure access-related strategies, communications, and materials comply with applicable laws, regulations, and industry standards.
- Providing legal guidance on market access, pricing, reimbursement, and government pricing obligations, including Medicaid Best Price, Average Manufacturer Price (AMP), Average Sales Price (ASP), 340B, and VA/FSS requirements.
Requirements
What you’ll need- Minimum of 5 years of legal experience with a top law firm, pharmaceutical company, biotech company, CRO or medical device company.
- Strong understanding of regulatory requirements related to product promotional activities and product pricing, fraud and abuse, and Stark and Anti-Kickback issues.
- Strong knowledge of laws, regulations, and guidance governing pharmaceutical commercial and market access activities, including FDA regulations, the Federal Food, Drug, and Cosmetic Act (FDCA), federal and state Anti-Kickback Statutes, beneficiary inducement rules, OIG guidance and advisory opinions, the False Claims Act, and the PhRMA Code.
- Excellent negotiation, drafting, and communication skills with the ability to convey complex legal concepts to non-legal stakeholders.
- Proactive, solution-oriented mindset with the ability to manage multiple priorities in a fast-paced environment.
- Active admission to practice law in your state of primary residence.
Benefits
Comp & perks- health, dental, and vision insurance
- paid holidays and PTO
- flexible work arrangements
- professional development opportunities and tools