At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

The Senior Director - Counsel, Manufacturing/Supply will be part of the Regulatory Legal Team

(RLT), which reports up through Lilly’s General Counsel and works across Lilly Legal and the Company with a highly cross-functional approach. RLT is a collaborative team of lawyers who collectively maintain the core legal expertise for the Company on regulatory law, including for clinical development and registration, manufacturing and quality, patient safety, environmental and other areas of law. RLT provides legal advice to teams and leadership across Lilly Research Laboratories and our affiliates worldwide.

Responsibilities

The primary responsibility of this position is to provide legal advice regarding regulations and strategy on drug manufacturing and supply in the U.S. and abroad. This will involve leveraging advice through collaboration with Lilly lawyers who work directly with product teams, litigation and business affiliates as well as outside counsel as required. Specific responsibilities include:

• Provide legal counsel that ensures Lilly manufacturing and quality incorporate the latest and cutting-edge interpretations of applicable laws, regulations, guidance, and harmonized

standards

• Stay current on the latest developments and trends related to manufacturing inspections and enforcement of good manufacturing practices, as well as applicable and emerging regulations and guidance documents

• Legal support for global regulatory inspections, including on-site participation for key

inspections as needed

• Counsel on supply chain matters, including wholesaler/distribution issues, product recalls, illegitimate and counterfeit products

•  Draft, revise and negotiate quality agreements

• Counsel on matters related to controlled substances

• Influence internal and external stakeholders regarding key policy initiatives (e.g., Drug Supply Chain and Security Act) including participation at select trade association meetings and other external activities

• Liaise and partner with International Business Unit representatives and legal teams to ensure appropriate connections are in place to facilitate one-voice, global counseling

Basic Requirements

• Bachelor’s and Juris Doctorate (or equivalent) Degrees

• Licensed to practice law

• Minimum 5-10 years of overall experience in a law firm or as an in-house lawyer in a medical device or pharmaceutical company

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

Additional Skills/Preferences

• Prior regulatory agency experience

• Some fluency/technical proficiency in manufacturing

• Demonstrated leadership and effectiveness in working with senior leadership

•  Ability to triage, prioritize and effectively counsel a high volume of inputs from a variety of sources

•  Highly motivated and collaborative partner with strong interpersonal skills and the ability to work effectively with team members, other lawyers, and members of management across all levels of the Company

• Good judgment and meticulous level of attention to detail

• Excellent written and verbal communication skills with an ability to influence others

• Demonstrated ability to appropriately handle highly confidential information

• Demonstrated dedication to expand knowledge and adapt to a changing environment

Other Information

• Remote/hybrid work may be acceptable

• No more than 10-15% travel is expected. The role may involve some travel to Lilly’s

manufacturing sites and, for remote roles located outside of Indianapolis, IN, occasional travel

to Lilly’s corporate headquarters located in Indianapolis.

Additional Information

Embracing diversity is at the core of our long-held value of respect for people. It is the lens through

which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.

#wearelilly

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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.

#WeAreLilly