Senior Director, Counsel, Diagnostics & Medical Devices

🔥 17 hours 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 global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 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 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

• 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

• 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