Senior Director, Counsel, Diagnostics & Medical Devices

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $199.5k - $321.2k / year

⏰ Full Time

🟠 Senior

⚖️ Legal Counsel / General Counsel

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• 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

• 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

• 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