Fda Attorney Jobs in Indiana (NOW HIRING)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Provide strategic and solutions-oriented counsel to a Lilly Business Unit as brand counsel for its product portfolio (therapeutic area(s) as assigned). This attorney will counsel business unit teams - including marketing, medical affairs, product development, and communications - on various legal matters including, but not limited to, FDA labeling and advertising requirements, U.S. and global clinical development and regulatory submissions, the Anti-Kickback Statute and its safe harbors, the False Claims Act, antitrust and unfair competition law, consumer protection, data rights and privacy, FTC commercial law, and business transactions. Depending on the therapeutic area assigned, additional subject matter may include laws and regulations pertaining to sponsored testing, Medicare coverage and reimbursement dynamics, and device or digital health considerations.

In this role, this attorney will work collaboratively with legal colleagues in other areas, business units, and affiliates, and must be proactive and adept in providing practical counsel in a fast-paced, dynamic, and innovative environment. The position will report to the applicable Business Unit General Counsel.

Activities in this role may include the following:

• Providing legal counsel and education on FDA labeling and promotional matters
• Collaborating with sales and marketing colleagues to advise on patient support and other programs consistent with healthcare fraud and abuse laws
• Educating business partners on potential legal implications of proposed marketing programs
• Advising on potential legal implications related to interactions with third parties relevant to the assigned therapeutic area (e.g., diagnostics companies, digital health partners)
• Participating as a core member of leadership teams responsible for U.S. brands and/or global product strategies
• Drafting, reviewing, and advising on various contracts related to Lilly assets, including collaborative research agreements
• Advising on data disclosures following clinical development achievements via press release and U.S. and international medical congresses, consistent with applicable laws and regulations

• US, Indianapolis preferred; remote candidates willing to travel to Indianapolis (or other locations) as needed will be considered.

• Bachelor's degree and JD degree from accredited schools
• Admitted to the bar in at least one of the fifty states; eligible to be admitted to the bar in Indiana under Indiana Admissions Rules
• Minimum of 10 years of relevant legal experience, with at least 4 years of experience in-house in a pharmaceutical or biotechnology company's law department

• Working knowledge and understanding of pharmaceutical marketing laws and regulations as generally practiced by innovative, multinational pharmaceutical manufacturers
• Experience with product counseling in the diabetes, obesity, cardiovascular, or oncology therapeutic areas
• Global mindset - familiarity or experience supporting global marketing and commercialization of pharmaceuticals worldwide or in jurisdictions outside the United States preferred
• Demonstrated experience with clinical collaborations, the Anti-Kickback Statute, competition law, pricing, and reimbursement/access issues as they pertain to the pharmaceutical industry, including Medicare
• Experience evaluating scientific communications for integrity and context, and applying principles for communicating truthful and non-misleading scientific information
• Experience evaluating sponsored testing programs for compliance
• Ability to manage multiple priorities in a fast-paced and evolving environment
• Demonstrated ability to assess and help business colleagues manage risk in a highly regulated environment
• Excellent oral and written communication skills, with a demonstrated ability to present complex information accurately and concisely to influence others at all levels of management, including C-suite executives
• Excellent analytical and organizational skills
• Sound judgment and issue-spotting ability
• Demonstrated learning agility and curiosity
• Strong interpersonal skills and ability to partner well with others
• Committed to teamwork and collaboration, both within Legal and with business partners
• Fluency in technology and appetite for applying technological solutions to simplify work and improve efficiency in the delivery of legal services
• Demonstrated ability to proactively identify opportunities for creative and innovative solutions

Some travel required (US and limited international)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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