Associate/Sr. Associate - R&D Operations COE Business Support

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.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

This is a 12 month FTC.

Overview

The purpose of the R&D COE Business Support team is to enables clinical and study teams to confidently work with external partners by ensuring robust third-party oversight. We translate ICH GCP and procedural requirements into practical,

inspection-ready execution across every study

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. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

• Ensure that clinical trial and study teams’ engagement with External Partners is fully compliant with the Third-Party procedure regarding third-party oversight, governance and in-turn inspection readiness.
• 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.
• Build and maintain quality internal relationships with cross functional teams, including but not limited to, Procurement, Clinical Development, and Clinical laboratory Sciences.
• In partnership with R&D Ops leadership, drive innovation within the third-party management process.

Minimum Qualification Requirements:

• Bachelor’s degree in a scientific, health-related, or business-related field
• At least 2 years of global drug development/discovery experience working with third parties.
• At least 2 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 conducting inspection readiness activities in support of the third-party management procedure and processes.
• Task focused with an ability to work to deadline.
• Strong business acumen, with an ability to manage complex external relationships, including alliance management.
• Strong Project Management skills.
• Strong understanding of compliance requirements (GCP, ICH Guidelines).
• 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.
• International travel may be required (15%)

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 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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