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)
(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)
- 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)
- 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:
- Good work/life balance
- Focused on FDA-regulated industry
- Variety in work and clientele
Questions about the role? Call, email or text us:
- Amanda Johnston, Sr. Attorney and Hiring Manager (763.639.6951, firstname.lastname@example.org)
- Mark Gardner, Managing Attorney, (612.382.7584, email@example.com)
- Tracy Erickson, Director of Finance & Administration, (612.382.7529, firstname.lastname@example.org)
Send your resume and cover letter to email@example.com.