Senior Counsel, Commercial and Compliance

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🕒 4 days ago

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MDWerks Inc.

WebsiteLinkedInAll Job Openings

1 - 10 employees

📱 Media

🤝 B2B

Media • B2B • Marketing

MDWerks Inc. is a dynamic company that specializes in press release distribution, enabling businesses to effectively share their news with media, investors, and consumers. The company utilizes targeted distribution options and innovative tools, such as an AI press release generator, to help clients streamline content creation and enhance their media visibility. MDWerks also offers a comprehensive media contacts database powered by AI to facilitate efficient outreach and improve engagement rates with journalists.

📋 Description

• 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