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 strategic counseling. Proven ability to collaborate effectively across business units while managing risks in a highly regulated environment.

Highest-signal resume keywords

JDLicensed To Practice Law7+ Years Legal ExperienceFDA Laws And RegulationsFraud And Abuse Counsel

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Applicant Tracking System Keywords

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Hard Skills

FDA LabelingMedical Device RegulationsAntitrust LawConsumer Protection LawData Rights And PrivacyFalse Claims ActPromotional ComplianceScientific Communications EvaluationRisk AssessmentSponsored Testing Programs

Soft Skills

Interpersonal SkillsTeamworkCollaborationSound JudgmentCommunication Skills

Tools & Technologies

Legal Technology Solutions

Certifications & Qualifications

Licensed To Practice Law

Industry Keywords

Medical DevicesIn Vitro DiagnosticsPharmaceuticalsBiotechnologyCommercial Strategy

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 FDA labeling and advertising, Anti-Kickback Statute safe harbors, False Claims Act, 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 fraud and abuse, promotional, and antitrust counsel across business units
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 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
Collaborate with legal colleagues, business units, and affiliates
Travel approximately 10% within the United States and possibly internationally

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 these
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 as practiced by innovative, multinational companies
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
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
Commitment to teamwork and collaboration
Excellent oral and written communication skills
Ability to present complex information accurately and concisely to influence all levels of management
Fluency in technology and appetite for applying technological solutions to improve legal-service delivery
Work authorization or visa sponsorship will not be provided

Benefits

Comp & perks

Company bonus based partly on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
Prescription drug benefits
Healthcare flexible spending accounts
Dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits
Employee assistance program
Fitness benefits
Employee clubs and activities
Equal opportunity and disability accommodation support