Associate/ Sr. Associate - R&D Operations - CT Third Party Management Oversight Lead

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.

R&D Operations - LRL Third Party Management

Purpose:

The purpose of the R&D Operations Center of Excellence (COE) is to enable productive external and internal interactions to achieve innovation goals by delivering the Right Assessment, Right Contract at the Right Time through the Right Analytics. The purpose of the R&D OPs – LRL Third Party Management team is to develop and deliver high performing operational processes specific to Lilly Research Lab’s (LRL) third party management, partnering with global functions, including Quality, Clinical Development, Medical, Legal, Procurement, Ethics & Compliance, and Working with Third Parties. In doing so, the R&D Operations Manager / Sr. Associate / Associate Consultant will always ensure an inspection ready mindset, through providing top-tier business support and managing third party organisation performance and compliance.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

• Ensure that business partner engagement with External Partners is fully compliant with all Lilly policies regarding Quality and Compliance, with a specific focus on the LRL Third Party Management procedure.
• Own and lead governance with regards Lilly’s fully outsourced trial model (FOT), including but not limited to driving compliance with the FOT Oversight Plan, supporting medical functions with their FOT transfer of training strategy, and assisting the FOT Global Process Lead (GPO) with subject matter expert queries.
• Implement Continuous Inspection Readiness Plan by working cross-functionally to ensure completion of actions, including, collection of contracts, operational documents, oversight plans, etc., support inspections with back/front room activities and contribute to process improvement of Inspection Readiness activities.
• Responsible for developing and maintaining inventory of current providers and associated approved services and capabilities in the Sourcing system; understand assigned vendors total capabilities, growth strategies & changing business direction and influence future MDU & Research strategy & vendor selection appropriately.
• Responsible for TPO (third party organization) metrics, include Quality, Compliance, On-time delivery, Spend, Risk and other trends.
• Serves as process owner for pan-LRL third party management processes within their responsibility area and ensure pan LRL integration of owned processes in partnership with functional management.
• In partnership with R&D Ops leadership, drive innovation that supports Lilly’s drug development/discovery transformation.

Minimum Qualification Requirements:

• Bachelor’s degree in a scientific, health-related, or business-related field, at a minimum.
• At least 5 years of working with third parties experience in a drug development / pharmaceutical setting.
• At least 3 years’ experience with project management tools and processes (e.g., management of integration scope, time, cost, quality, human resources, communications, risk, and procurement).
• At least 3 years utilizing required technology & tools (i.e., Microsoft Office, SAP, Veeva, Oracle databases, Lilly SharePoint, etc..).

Other Information/Additional Preferences:

• Experience with pharmaceutical clinical trials, e.g., leading / supporting a clinical trial at a site level.
• Strong track record of interdependent leadership of cross-functional and improvement teams, including the ability to influence without direct authority, at the executive management, middle management and individual levels.
• Experience conducting inspection readiness activities in support of the third-party management procedure and processes.
• Strong business acumen, with an ability to manage complex external relationships, including alliance management.
• Strong Project/Portfolio Management skills.
• Strong knowledge of quality systems.
• Strong understanding of compliance requirements (GxP, Anti-corruption, FRAP, Privacy)
• Experience in leading global process improvement, or business operations with a minimum of 5 years’ experience doing one or the other or both with an established track record of success.
• Strong ability to lead change.
• Strategic / critical thinking skills.
• Strong ability to manage and influence functional and project leadership in project/portfolio-facing decisions.
• Excellent interpersonal skills reflecting leadership and the ability to create a supportive work climate that values diversity and inspires teamwork.
• Sophisticated qualitative and quantitative analytic experience needed to build and implement strategies and business system process improvements; a record of anticipating problems and creating process solutions.

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 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.

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