Careers

APPLY VIA LINKEDIN HERE

Reports to: Managing Attorney

Industry: Law Practice (FDA-regulated industry)

Employment Type: Full-time

Location: Flexible (office located in greater Minneapolis/St. Paul area)

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: February 16, 2024

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 anti-fraud compliance matters, e.g., health care compliance auditing and monitoring experience. (E)
• Knowledge of health care laws and regulations (e.g., Food, Drug and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and Physician Payments Sunshine Act (PPSA)). (E) 
• Demonstrates ability to lead projects. (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 company lawyers, 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:

• Outsourced compliance function
• Designing and implementing compliance programs 
• Monitoring and auditing 
• Training management teams and staff on compliance laws and regulations 
• Analyzing sales and marketing programs for compliance with FDA, CMS, OIG, OCR, FTC requirements 
• Assisting companies subject to Corporate Integrity Agreements (CIA)
• Investigating allegations and hotline reports 
• Reviewing discounting practices for Discount Safe Harbor compliance 
• Analyzing transfers of value to HCPs for compliance with the Personal Services and Management Contracts Safe Harbor 
• Reviewing reimbursement support services and program hubs 
• Conducting compliance audits and compliance risk assessments of commercial activities 
• Helping to mitigate, wind-down, and/or terminate risky practices 
• Performing healthcare and FDA regulatory due diligence for buyers and sellers 
• Training on best documentation practices 
• Reviewing contracts 
• Auditing against the PhRMA and AdvaMed Codes 
• Transparency (sunshine) reporting to federal, state, municipal authorities
  

Benefits:

• Flexible work environment.
• Highly competitive compensation package.
• Opportunity to be a part of a high-performing distinguished team.
• Mentoring and coaching opportunities (giving and receiving).
• Firm commitment to work-life balance, health, and well-being.
• Medical, disability and life insurance benefits.
• Bonus program.
• 401(k) match.
• Open vacation.
• Tuition assistance for work-related certifications and training.
• Trail-blazing best-in-class clientele.

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.
• Opportunity for growth and advancement.

Send resume and cover letter outlining how you fit the role along with examples of demonstrated leadership abilities to Tracy Erickson, MAcc, C.P.A., CFO & COO at terickson@gardner.law or apply via LinkedIn.

About Gardner Law

Gardner Law is an FDA law firm that specializes in regulatory, compliance and privacy. Saving patients’ lives and improving people’s health is our purpose at Gardner Law and it guides everything we do.

APPLY VIA LINKEDIN HERE

Reports to: Senior Attorney

Industry: Law Practice (FDA-regulated industry)

Employment Type: Full-time

Location: Flexible (office located in greater Minneapolis/St. Paul area)

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: January 25, 2024

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 FDA regulatory matters, including medical device submissions, regulatory strategy, and advertising and promotion review and processes. 
• Possess medical device submission (e.g., 510(k), PMA, IDE, De Novo, EUA) and advertising and promotion review knowledge. (E) 
• Knowledge of health care laws and regulations (e.g., Food, Drug and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and Physician Payments Sunshine Act (PPSA)). (E) 
• Demonstrates ability to lead projects. (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 company lawyers, 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:

• Making FDA regulatory submissions (e.g., 510(k), PMA, IDE, De Novo, EUA). 
• Anti-fraud and FDA compliance review of promotional materials and commercial programs.
  
• Drafting opinions regarding compliance with various laws including: FDCA, AKS, FCA, PPSA, HIPAA, among others. 
• FDA meetings. 
• Performing research. 
• Serving on promotional material and scientific material review teams. 
• Advising clients on compliant interactions with health care professionals.
  

Benefits:

• Flexible work environment.
• Highly competitive compensation package.
• Opportunity to be a part of a high-performing distinguished team.
• Mentoring and coaching opportunities (giving and receiving).
• Firm commitment to work-life balance, health, and well-being.
• Medical, disability and life insurance benefits.
• Bonus program.
• 401(k) match.
• Open vacation.
• Tuition assistance for work-related certifications and training.
• Trail-blazing best-in-class clientele.

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.
• Opportunity for growth and advancement.

Send resume and cover letter outlining how you fit the role along with examples of demonstrated leadership abilities to Tracy Erickson, MAcc, C.P.A., CFO & COO at terickson@gardner.law or apply via LinkedIn.

About Gardner Law

Gardner Law is an FDA law firm that specializes in regulatory, compliance and privacy. Saving patients’ lives and improving people’s health is our purpose at Gardner Law and it guides everything we do.

APPLY VIA LINKEDIN HERE

Reports to: Senior Attorney

Industry: Law Practice (FDA-regulated industry)

Employment Type: Full-time

Location: Flexible (office located in greater Minneapolis/St. Paul area)

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: January 25, 2024

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

• 3+ 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) 
• Knowledge of privacy laws and regulations (e.g., HIPAA, HITECH, GDPR, CCPA, CAN-SPAM, TCPA, and FTC) (E) 
• Knowledge of health care laws and regulations (e.g., Food, Drug and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and Physician Payments Sunshine Act (PPSA)). (E) 
• Demonstrates ability to lead projects. (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 company lawyers, 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:

• Reviewing for compliance with privacy and cybersecurity requirements, including HIPAA, HITECH, FTCA, GDPR, CCPA, CAN-SPAM, TCPA and other laws 
• Designing, drafting, implementing, and reviewing privacy policies and procedures 
• Evaluating marketing programs for privacy compliance
  
• Reviewing and negotiating business associate agreements, data processing agreements, privacy clauses, standard contractual clauses, and other privacy agreements 
• Auditing privacy and cybersecurity programs including inquiries based on standards such as ISO 27001, NIST, and others 
• Assisting manufacturers building HIPAA compliance programs as a business associate or covered entity 
• Performing privacy officer or data protection officer services on a contract basis 
• Privacy training for organizations including general privacy matters, as well as case coverage and complaint handling 
• Reviewing and evaluating products, applications and websites for privacy compliance, including contact forms, opt-in consents, privacy policies 
• Drafting patient authorizations and consents 
• Supporting privacy and security incident matters 
• Assisting manufacturers with clinical trials, including data transfer agreements, transfer impact assessments, informed consent, privacy notices, and advice on use of patient data 
• Assessing the application of privacy requirements with mandated FDA reporting and data collection 
• Reviewing commercial field activities for privacy compliance
  

Benefits:

• Flexible work environment.
• Highly competitive compensation package.
• Opportunity to be a part of a high-performing distinguished team.
• Mentoring and coaching opportunities (giving and receiving).
• Firm commitment to work-life balance, health, and well-being.
• Medical, disability and life insurance benefits.
• Bonus program.
• 401(k) match.
• Open vacation.
• Tuition assistance for work-related certifications and training.
• Trail-blazing best-in-class clientele.

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.
• Opportunity for growth and advancement.

Send resume and cover letter outlining how you fit the role along with examples of demonstrated leadership abilities to Tracy Erickson, MAcc, C.P.A., CFO & COO at terickson@gardner.law or apply via LinkedIn.

About Gardner Law

Gardner Law is an FDA law firm that specializes in regulatory, compliance and privacy. Saving patients’ lives and improving people’s health is our purpose at Gardner Law and it guides everything we do.

APPLY VIA LINKEDIN HERE

Reports to: CFO/VP of Operations

Industry: Law Practice (FDA-regulated industry)

Employment Type: Full-time

Location: Flexible (office located in greater Minneapolis/St. Paul area)

Level: Mid-level

Hours of Work: Varies

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

Date posted: April 19, 2024

Job Summary

Our legal office is expanding, and we’re looking for an experienced marketing manager to help us continue to grow. As the leader of the marketing, you’ll help implement and execute winning online and offline advertising strategies that promote our legal services and uphold our brand image. Experience in the legal or healthcare industry is preferred but not required. The ideal candidate for this position is an innovative thinker and multitasker who loves bringing creative ideas to the table. This person would also be the “CEO” of our service product offerings by creating the vision to align with business goals, understand how our services can best meet the needs of our customers, and by collaborating with the cross functional team.

Job Responsibilities:

• Establish a strategic marketing plan that effectively promotes our legal firm and drives revenue growth
• Develop and maintain all branding and messaging for the firm
• Conduct market research and analysis to identify customer needs, market trends, and competitive landscape

• Tracks key metrics and analyzes data to understand product performance and drive improvements.

• Develop content for digital marketing campaigns including email, social media, and online advertisements
• Coordinate all marketing aspects of webinars and in-person education seminars
• Manage social media and website content, mailing lists, SEO development, and data analytics to ensure all content is up to date and relevant
• Develop and deliver business analytics across practice areas, geographies and platforms
• Handle the copywriting and image creation for all outgoing print marketing materials including to ensure the firm is presented professionally

• Prioritizes features and initiatives based on user value and business impact.
• Ensures cross-team communication and collaboration, keeping everyone on the same page about product service goals and progress.

Job Qualifications:

• Bachelor’s degree in Marketing or related majors
• 5+ years of experience in Marketing or related field
• Some experience or a strong interest in the legal or healthcare industry is preferred
• Familiarity with web platforms, email systems, social media, public relations, and brand identity - graphic design skills are a plus
• Candidates must be able to manage multiple projects with varied timelines on tight deadlines

• Strategic thinking, strong written and verbal communication skills, analytical mindset, empathy, and technical understanding of our service product offerings.

• Experience with Craft, Constant Contact, Google Analytics are a plus

Benefits:

• Flexible work environment.
• Highly competitive compensation package.
• Opportunity to be a part of a high-performing distinguished team.
• Mentoring and coaching opportunities (giving and receiving).
• Firm commitment to work-life balance, health, and well-being.
• Medical, disability and life insurance benefits.
• Bonus program.
• 401(k) match.
• Open vacation.
• Tuition assistance for work-related certifications and training.
• Trail-blazing best-in-class clientele.

Words our employees use to describe Gardner Law:

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

Send resume and cover letter to Tracy Erickson at terickson@gardner.law.

About Gardner Law

Gardner Law is an FDA law firm that specializes in regulatory, compliance and privacy. Saving patients’ lives and improving people’s health is our purpose at Gardner Law and it guides everything we do.