Legal Manager

Company: Eli Lilly
Location: Indianapolis
Posted on: March 20, 2023

Job Description:

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 35,000 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.

The purpose of the Legal Manager role is to support and facilitate, under the supervision of a licensed attorney, the development of (1) promotional messages that educate healthcare professionals, patients and payers about the benefits and risks of Lilly products; and (2) non-promotional medical deliverables to provide accurate, balanced and timely scientific information about our medicines and disease states to improve patient outcomes. In addition to working with a team of cross-functional partners from Lilly Legal, this role collaborates with regulatory, medical and marketing personnel and other team members. To accomplish this purpose, it is necessary for the Legal Manager to develop collegial and mutually productive relationships across Lilly (and alliance partner company, when applicable) components. Further, the Legal Manager should develop an expertise over time in FDA promotional regulations and counseling the US Brand and Medical Affairs teams on the application of those regulations to their decisions. The position will report to an Associate Director, Commercial/Consumer Operations.

Specific responsibilities may include the following:

Providing legal expertise to the US Brand Teams (and partner companies when applicable) to ensure:

• Compliance with all applicable regulations, internal policies and internal quality systems
• High quality, timely and decisive legal advice (with appropriate consultation and supervision of licensed legal professionals) to allow business partners to make well-informed decisions
• Development of promotional messages that educate customers about the benefits and risks of Lilly products by introducing multiple alternative approaches that may meet the business objectives while maintaining compliance with applicable regulations and internal policies
• Support implementation of the Customer Information Quality (CIQ) system, including development and review of product and disease state communications within the CIQ processes
• Ensure legal requirements are met for projects
• Actively engage in making recommendations regarding proposed promotional activity plans in the US Providing leadership to the US and Global Brand Teams in collaboration with global product attorneys by:
  • Proactive leadership in the critical review of promotional strategies for Lilly marketed products
  • Taking a proactive leadership role in the critical review of proposed Medical Affairs activities
  • Establishing trust and credibility through outstanding legal knowledge and ability to influence others in a manner that advances enterprise goals and objectives
  • Assertively managing timelines and elevating productivity of the teams in the creation of materials by setting priorities, finding innovative ways of doing essential work, and improving quality
  • Taking leadership in ensuring the success of our business collaborations Exercise accountability for knowledge transfer across Lilly Legal and the broader enterprise by/with:
    • Sharing takeaways with the Business Unit Legal Team (BULT) regarding the practical implementation of the advertising and labeling regulations
    • Regularly communicating with other parts of the legal organization (i.e., labeling, safety) to facilitate sharing of information that allows the entire function to more effectively support pre- and post-approval teams
    • Ongoing monitoring and communication of factors and trends in the external environment related to advertising and promotion topics from OPDP enforcement actions to BULT and US Brand Teams as relevant
    • Communicating findings regarding Lilly interactions with OPDP in promotional review process
    • Supporting implementation of internal promotional guidelines and standards
    • Attending internal and external training programs, FDLI and other trade meetings Are you a highly motivated and collaborative partner with strong interpersonal skills and the ability to work effectively with team members, other lawyers, regulatory, medical and US Brand team leadership? Consider joining our team striving to drive our mission of helping to improve patient lives!
      
      Basic Qualifications:
      • Bachelor Degree (Paralegal Studies preferred)
      • A minimum of 3 years of relevant experience providing legal services preferably in a regulated environment, in house at a pharmaceutical or biotechnology company's law department or as a paralegal in a law firm working with clients in a regulated industry or a combination of the two
      • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position Additional Skills/Preferences:
        • Industry-related experience and knowledge of FDA regulations and practices across Review Divisions and OPDP (CFR guidelines, FDAMA, Guidances, etc.) and awareness of evolving regulatory reform initiatives
        • Proven track record to drive solutions that impact the U.S. affiliate (i.e. across business units) and/or globally
        • Demonstrated ability to influence people and decisions
        • Proven ability to assess and handle risk in a highly regulated environment
        • Strong analytical skills and ability to craft innovation solutions to complex issues, focusing on simplicity and practicality
        • Good judgment and a meticulous level of attention to detail
        • Excellent written and verbal communication skills with an ability to effectively communicate legal issues and influence others at all levels of the company
        • Demonstrated dedication to expand knowledge and adapt to a changing environment
          
          Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
          
          Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
          
          As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
          
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