Senior Director, Counsel, Diagnostics – Medical Devices

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $199.5k - $321.2k / year

⏰ Full Time

🟠 Senior

⚖️ Legal Counsel / General Counsel

👻 Ghost score 0%

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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, 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

• 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

• 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