Senior Director, Counsel, Diagnostics & Medical Devices

Eli Lilly and Company

. Provide strategic and solutions-oriented counseling to the Neuroscience Business Unit and other Lilly business units on diagnostic and device issues related to commercial strategy .

Posted 10/19/2026full-timeRemote • United StatesSenior💰 $199,500 - $321,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive legal expertise in FDA laws and regulations related to diagnostics and medical devices, with a strong focus on compliance, marketing laws, and risk management. Proven ability to provide strategic legal counsel and collaborate effectively with cross-functional teams in a fast-paced environment.

Highest-signal resume keywords

JDLicensed To Practice LawFDA Laws And RegulationsMedical Device And Pharmaceutical Marketing LawsFraud And Abuse Compliance

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Applicant Tracking System Keywords

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Hard Skills

Legal CounselingRegulatory ComplianceRisk AssessmentIssue SpottingScientific Communication Evaluation

Soft Skills

Interpersonal SkillsTeamworkCollaborationOral CommunicationWritten Communication

Tools & Technologies

Technological Solutions

Certifications & Qualifications

Licensed To Practice Law

Industry Keywords

DiagnosticsMedical DevicesFDA LabelingAnti-Kickback StatuteFalse Claims ActAntitrust LawConsumer ProtectionData RightsFTC Commercial LawSponsored Testing Programs

About the role

Key responsibilities & impact

Provide strategic and solutions-oriented counseling to the Neuroscience Business Unit and other Lilly business units on diagnostic and device issues related to commercial strategy
Counsel marketing, medical affairs, and related teams on commercial legal matters involving diagnostics, including FDA labeling and advertising requirements, the Anti-Kickback Statute and its safe harbors, the False Claims Act, antitrust, unfair competition law, consumer protection, data rights and privacy, FTC commercial law, and business transactions
Provide legal counsel and education on FDA labeling and promotional matters for diagnostic products, medical devices, and pharmaceuticals
Provide diagnostics- and device-related fraud and abuse, promotional, and antitrust counsel
Collaborate with sales and marketing colleagues on device- or diagnostic-related patient support and consumer programs
Educate business partners on legal implications of proposed marketing tactics
Advise on legal implications of interactions with third parties, including diagnostics companies and software/digital health companies
Counsel on sponsored testing programs
Participate as a core member of leadership teams responsible for diagnostics- and device-related brand and product strategies
Work collaboratively with legal colleagues, business units, and affiliates

Requirements

What you’ll need

Bachelor's degree and JD
Licensed to practice law in at least one of the 50 States
Minimum of 7 years of relevant legal experience
Experience practicing as a member of a law firm with a nationally recognized practice in medical devices and in vitro diagnostics, in-house at a medical device, laboratory or diagnostics company law department, in-house in a pharmaceutical or biotechnology company's law department, or a combination of the foregoing
Qualified applicants must be authorized to work in the United States on a full-time basis
Deep knowledge and understanding of FDA laws and regulations pertaining to diagnostics and medical devices, including Medical Device Amendments of 1976 to the FDCA, CLIA, and state laws
Knowledge of device and pharmaceutical marketing laws and regulations
Experience with fraud and abuse, promotional, and antitrust matters
Experience evaluating sponsored testing programs for compliance
Experience evaluating scientific communications and applying principles for communicating truthful and non-misleading scientific information
Ability to manage multiple priorities in a fast-paced and evolving environment
Ability to assess and help business colleagues manage risks in a highly regulated environment
Sound judgment and issue-spotting ability
Strong interpersonal skills and ability to partner well with others
Teamwork and collaboration
Excellent oral and written communication skills, with ability to present complex information accurately and concisely to influence others at all levels of management
Fluency in technology and appetite for applying technological solutions to simplify work and improve efficiency in delivery of legal services

Benefits

Comp & perks

Company bonus, depending in part on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities