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Location Minnesota - Stillwater
Job ID ZM2M197227
Health CareLitigation - Regulatory Enforcement (SEC Telecom Energy FDA etc.)
Stillwater office of our client seeks an entry- to mid-level associate attorney with 2+ years of experience working in the industry (e.g., medical device or drug company). The candidate will draft and make submissions to the FDA (e.g., 510(k)s, IDEs, PMAs, NDAs, INDs, De Novo's). Will perform regulatory assessments of promotional materials (e.g., brochures, advertising, websites, social media posts, reimbursement materials, and marketing programs). Conduct legal and regulatory research. Communicate with the FDA as a client advocate (e.g., FDA pre-sub meetings, RFDs, and other FDA communications). Draft opinions regarding compliance with FDCA, AKS, FCA, PPSA, HIPAA, and other laws and industry codes. Design, deploy, manage, audit, and/or monitor health care compliance programs. Evaluate grant requests, clinical research arrangements, co-marketing programs, fee-for-service arrangements, government reporting, discounts, and sampling practices. Counsel clients on scientific exchange and reimbursement support. Draft and review research-related agreements (e.g., CTAs, ICFs, FUAs). Perform legal and regulatory training for clients. Respond to and resolve complaints made to clients by regulators and competitors. Support firm staff with QMS evaluations and remediation. Evaluate client practices for privacy compliance. Experience with FDA regulatory submissions and advertising/promotional review is required. Should be knowledgeable of health care laws and regulations (e.g., Food, Drug and Cosmetic Act (FDCA); Anti-Kickback Statute (AKS); False Claims Act (FCA); Physician Payments Sunshine Act (PPSA); and HIPAA). Must be licensed and in good standing to practice law in a US state. Admission to any federal district court would be preferred.
The candidate should have a Bachelor of Arts or Bachelor of Science degree. J.D. degree or equivalent from an ABA-approved law school is required. Should preferably have advanced degrees, licenses, or certifications such as M.D., MBA, Ph.D., MSc, MPH, RAC, or CPA. The ability to work productively with individuals with opposing viewpoints and strong personalities, including high-level company executives and regulators, is essential. The ability to write and speak in an effective, persuasive, and concise manner is required. The ability to analyze disparate information quickly and design effective and practical solutions to problems is a must.
This boutique law firm provides exclusive legal counsel to FDA-regulated companies in medical technology, biotechnology, and pharmaceutical industries. Its practice areas include compliance, ad promo review, sunshine reporting, regulatory, quality, enforcement, clinical, and privacy. Its team of attorneys has decades of experience in these areas. The firm's office is located in Stillwater, Minnesota.
Your information will not be forwarded to any employers at this time. A recruiter will contact you with more information once our internal review of your resume is completed.
200 South Wacker Drive, 31st FloorChicago,Illinois 60606
Phone (312) 321-9411
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