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Careers

Position: Associate Attorney

Reports to: Senior Attorney

Industry: Law Practice

Employment Type: Full-time

Location: Flexible

Licensure: Unrestricted license to practice law in a U.S. state

Preferred License: Admission to any federal district court

Level: mid-level

Exempt Status: Exempt

Hours of Work: Varies

Travel Required: Yes (minimal, e.g., <5%)

Date posted: October 3rd, 2022

Qualifications, (E) = essential to job, (P) = preferred:

  • 2+ years of experience working in industry at a medical device, pharmaceutical, biologic, or diagnostic company, e.g., working in Legal, Regulatory Affairs, Quality Affairs, Clinical Affairs, Product Management, R&D, or a related role. (E)
  • Experience with health care laws and regulations (g., Food, Drug and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and Physician Payments Sunshine Act (PPSA)). (E)
  • Experience with health care anti-fraud compliance matters, e.g., health care compliance auditing and monitoring experience. (E)
  • Experience with FDA regulatory matters, including advertising and promotion review. (E)
  • Knowledge of privacy laws and regulations (e.g., HIPAA, HITECH, GDPR, CCPA, and FTC). (P)
  • Demonstrates ability to lead projects and teams. (E)
  • Responsive, persistent, and capable of managing numerous assignments and responsibilities simultaneously in a dynamic and fast-paced environment while meeting goals and deadlines. (E)
  • Flexible, independent, and self-starting. (E)
  • Collaborative, business-minded, and not combative. (E)
  • Ability to work productively with individuals with opposing viewpoints and strong personalities, including high-level company executives and regulators. (E)
  • Exceptional attention to detail. (E)
  • Ability to write and speak in an effective, persuasive and concise manner. (E)
  • Ability to analyze disparate information quickly and design effective and practical solutions to problems. (E)
  • Bachelor of Arts or Bachelor of Science. (E)
  • Juris Doctor (or equivalent) from an ABA-approved law school. (E)
  • Licensed and in good standing to practice law in a U.S. state. (E)
  • Strong grasp of and attention to ethics laws and the Model Rules of Professional Conduct. (E)
  • Advanced degrees, licenses, certifications favored, e.g., MD, MBA, PhD, MSc, MPH, RAC, CPA. (P)

Primary functions:

  • Drafting opinions regarding compliance with various laws including: FDCA, AKS, FCA, PPSA, HIPAA, among others.
  • Anti-fraud and FDA compliance review of promotional materials and commercial programs.
  • Serving as “compliance officer” for clients.
  • Advising clients on compliant interactions with health care professionals.
  • Designing and deploying compliance programs.
  • Performing investigations.
  • Auditing and monitoring compliance programs.
  • Serving on promotional material and scientific material review teams.
  • Training client staff on FDA and anti-fraud requirements, among others.
  • Responding to complaints from client competitors and regulators.
  • Performing diligence for buyers and sellers.
  • Working with other teammates to execute on client deliverables.

Benefits:

  • Flexible work environment.
  • Highly competitive compensation package.
  • Opportunity to be a part of, and advance on, a high-performing A-caliber team.
  • Employees mentored and coached by experienced leadership.
  • Firm commitment to work-life balance, health, and well-being.
  • Bonus program.
  • 401(k) match.
  • Medical, disability and life insurance benefits.
  • Tuition assistance for work-related certifications and training.
  • High-quality, interesting, and sophisticated work assignments.
  • Trail-blazing clientele include manufacturers of advanced medical technologies, pharmaceuticals, biologics, and diagnostics.
  • No client acquisition expectations.
  • No “big law” billing requirements.

Words our employees use to describe Gardner Law:

  • Rewarding
  • Good work/life balance
  • Variety in work and clientele
  • Collaborative
  • Flexible
  • Independent
  • Fast-paced
  • Impactful
  • Focused on FDA-regulated industry
  • Employee growth-oriented

Interested? Send resume and cover letter outlining how you fit the role along with examples of demonstrated leadership abilities to:

About Gardner Law

Gardner Law provides legal and regulatory counsel to medical technology and pharmaceutical companies on FDA, anti-fraud and privacy matters. Our experienced staff have worked in industry or at the FDA. We provide practical advice to leaders around the world at all stages of the product life cycle, from ideation, R&D, clinical testing and regulatory submission, to manufacturing and commercialization.

Representative matters involve:

  • FDA approval pathways, quality and regulatory assessments.
  • Compliance assessments.
  • Compliance programs, investigations, & training.
  • Advertising and promotion review.
  • Guidance on interactions with healthcare professionals.
  • Government enforcement.
  • Government reporting.
  • Clinical research.
  • Privacy matters.

Phone: 612.382.7584

Twitter: @markegardner @GardnerPllc

Website: gardner.law

Careers: www.gardner.law/careers/

Alerts: www.gardner.law/alerts/

YouTube: https://www.youtube.com/channel/UC9-uPh7raNGcs_-yUuFqlww