Career Opportunities at Gardner Law

Position: Associate Attorney
Reports to: Senior Attorney
Location: Remote (working at Minnesota office not compulsory)
Licensure: Unrestricted license to practice law in a U.S. state
Preferred License: Admission to any federal district court
Level: Entry- to mid- level
Exempt Status: Exempt
Hours of Work: Varies
Travel Required: Yes (not extensive, e.g., <5%)
Date posted: December 22, 2020 (updated)

 

Qualifications
(E) = essential
(P) = preferred

  • Experience with FDA regulatory submissions and advertising/promotional review. (E)
  • 2+ years of experience working in industry (e.g., medical device or drug company). (E)
  • 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); HIPAA). (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)
  • Ability to write and speak in an effective, persuasive and concise manner. (E)
  • Exceptional attention to detail. (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 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 and making submissions to the FDA (e.g., 510(k)s, IDEs, PMAs, NDAs, INDs, De Novo's). (E)
  • Performing regulatory assessments of promotional materials (e.g., brochures, advertising, websites, social media posts, reimbursement materials, and marketing programs). (E)
  • Conducting legal and regulatory research. (E)
  • Communicating with the FDA as a client advocate (e.g., FDA pre-sub meetings, RFDs, and other FDA communications). (P)
  • Draft opinions regarding compliance with FDCA, AKS, FCA, PPSA, HIPAA, and other laws and industry codes. (P)
  • Design, deploy, manage, audit, and/or monitor health care compliance programs. (P)
  • Evaluate grant requests, clinical research arrangements, co-marketing programs, fee-for-service arrangements, government reporting, discounts, and sampling practices. (P)
  • Counsel clients on scientific exchange and reimbursement support. (P)
  • Draft and review research-related agreements (e.g., CTAs, ICFs, FUAs). (P)
  • Performing legal and regulatory training for clients. (P)
  • Respond to and resolve complaints made to clients by regulators and competitors. (P)
  • Support firm staff with QMS evaluations and remediation. (P)
  • Evaluate client practices for privacy compliance. (P)

Benefits:

  • Leadership commitment to work-life balance, health, and well-being.
  • Flexible work environment.
  • Excellent compensation package.
  • Bonus program.
  • 401(k) match.
  • Paid vacation.
  • Health insurance allowance.
  • Tuition assistance for work-related certifications.
  • Opportunity to work with a talented, strong, A-caliber team.
  • Employees are mentored and developed by experienced firm leadership.
  • High-quality, interesting, and sophisticated work assignments.
  • Clientele includes trail-blazing manufacturers of advanced medical technologies, pharmaceuticals, and biologics.
  • No client acquisition expectations.
  • No "big law" billing requirements.
  • Place to grow.

Words our attorneys use to describe their job at Gardner Law:

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

Questions about the role? Call, email or text us:

Send your resume and cover letter to terickson@gardner.law.