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 10/16/2026full-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 commercial strategy, compliance, and risk management. Proven ability to collaborate effectively across business units while providing strategic legal counsel on marketing and promotional matters.

Highest-signal resume keywords

JDLicensed To Practice LawFDA Laws And RegulationsFraud And Abuse ComplianceMedical Device Marketing Laws

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Hard Skills

Legal CounselingRegulatory ComplianceAntitrust LawPromotional LawDiagnostics LawMedical Device LawRisk AssessmentSponsored Testing Program EvaluationScientific Communication Evaluation

Soft Skills

Interpersonal SkillsTeamworkCollaborationSound JudgmentCommunication Skills

Tools & Technologies

Digital Health SolutionsTechnology Applications

Certifications & Qualifications

Licensed To Practice Law In The United States

Industry Keywords

DiagnosticsMedical DevicesPharmaceuticalsFDA LabelingConsumer ProtectionData RightsFTC Commercial LawIn Vitro DiagnosticsCLIA

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, FDA labeling and advertising, fraud and abuse, antitrust, unfair competition, 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 across business units as assigned
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 diagnostics, software, and 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
Collaborate with legal colleagues, business units, and affiliates
Travel approximately 10%, including US and possibly limited international travel

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 at a law firm with a nationally recognized medical devices and in vitro diagnostics practice, 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
Authorized to work in the United States on a full-time basis
Deep knowledge of FDA laws and regulations pertaining to diagnostics and medical devices, including the 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 truthful and non-misleading scientific information
Familiarity or experience supporting global marketing and commercialization of diagnostics or pharmaceuticals is a plus
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
Fluency in technology and appetite for applying technological solutions to simplify work and improve efficiency

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
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities