Senior Counsel, Commercial and Compliance

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MDWerks Inc.

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1 - 10 funcionários

📱 Mídia

🤝 B2B

Media • B2B • Marketing

A MDWerks Inc. é uma empresa dinâmica que se especializa na distribuição de comunicados de imprensa, permitindo que as empresas compartilhem suas notícias de forma eficaz com a mídia, investidores e consumidores. A empresa utiliza opções de distribuição direcionadas e ferramentas inovadoras, como um gerador de comunicados de imprensa com IA, para ajudar os clientes a simplificar a criação de conteúdo e aumentar sua visibilidade na mídia. A MDWerks também oferece um banco de dados abrangente de contatos de mídia, alimentado por IA, para facilitar o alcance eficiente e melhorar as taxas de engajamento com jornalistas.

Descrição

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

• medical • dental • vision • time off • 401K