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 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\xe2\x80\x99re looking for people who are determined to make life better for people around the world.

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.
1. System Development & Maintenance (40%)
\xe2\x96\xaa Responsible for the support and/or development of new or existing systems, tools, and technologies for GPS
systems.
\xe2\x96\xaa Uses standard validation principles and system development methodologies to create and maintain GPS-based applications for use in operations and processes.
\xe2\x96\xaa Strategically influence and drive the change management process for GPS owned systems.
\xe2\x96\xaa Knowledge of data migration/data transfer process involving GPS data.
\xe2\x96\xaa Responsible for the configuration of GPS safety system such as global reporting rules and conducting Product License Study (PLS) activities.
\xe2\x96\xaa Acts as a SME for GPS system configuration activities (i.e. ERR and PLS processes).
2. Safety Reporting (30%)
\xe2\x96\xaa Supports GPS and Lilly safety reporting needs through the creation of existing/adhoc queries and/or visualizations.
\xe2\x96\xaa Maintains an understanding of GPS systems data in order to ensure reports meet GPS/Lilly needs.
\xe2\x96\xaa Ensures appropriate review and validation of output for accuracy.
3. Operational Excellence (20%)
\xe2\x96\xaa Provides support to GPS functional areas; interacts with GPS therapeutic teams; facilitates consistency of business practices; assists with the identification and resolutions of process gaps or improvement opportunities; provides input to leadership regarding performance measures and data validation.
\xe2\x96\xaa Proactively communicates with customers, teammates, vendors, and IT groups to align on safety report request requirements and delivery timing.
\xe2\x96\xaa Looks for opportunities to create self-service/enhanced reporting options for GPS/Lilly functional areas.
\xe2\x96\xaa Works across GPS to leverage performance data, compare observations to standards, influence strategic direction, and drive capability improvements.
\xe2\x96\xaa Understanding of safety process knowledge in order to lead/participate in projects across GPS that drive GPS automation, technology and analytics needs.
\xe2\x96\xaa Active engagement in benchmarking in order to highlight opportunities for automation and technology improvements in GPS processes.
4. Compliance (10%)
\xe2\x96\xaa Provide standard or custom validated reports for use in audits and inspections.
\xe2\x96\xaa Maintains accuracy and performance of routine reports executed by or for GPS. Prepares and maintains records to provide information for summaries, charts, graphs, and monthly or ad-hoc reports.
\xe2\x96\xaa Maintains awareness of existing regulations/guidelines to ensure alignment of deliverables within standard operating expectations.
\xe2\x96\xaa Understands the confidential nature of company information and takes necessary steps to ensure its protection and compliance with all standards.
\xe2\x96\xaa Understand the roles of the EU Qualified Person (QP) and ensures support is provided to fulfill the QP legal responsibilities.

Minimum Qualification Requirements:
\xe2\x96\xaa Master\'s/Bachelor\xe2\x80\x99s degree within a health science, Mathematics, Statistics, Computer Science field or equivalent experience.
\xe2\x96\xaa Demonstrates experience with data, reporting, and processes/systems.

Other Information/Additional Preferences:
\xe2\x96\xaa Experience in the pharmaceutical industry and/or demonstrated understanding of pharmacovigilance or clinical research.
\xe2\x96\xaa Demonstrated understanding of the GPS safety system and business process.
\xe2\x96\xaa Experience working in a highly regulated environment.
\xe2\x96\xaa Demonstrated working knowledge and application of Computer System Quality (CSQ) requirements.
\xe2\x96\xaa Demonstrated experience with using data analysis and visualization tools (i.e. Excel, Business Objects, Power BI).
\xe2\x96\xaa Experience using Microsoft Tool Suite (i.e. SharePoint, MS Flows, etc.)
\xe2\x96\xaa Ability to work in a virtual team environment.
\xe2\x96\xaa Strong interpersonal and leadership skills.
\xe2\x96\xaa Excellent oral and written communication skills.
\xe2\x96\xaa Process management expertise.
\xe2\x96\xaa Ability to effectively collaborate with others.
\xe2\x96\xaa Critical thinking skills.
\xe2\x96\xaa Attention to detail.
\xe2\x96\xaa Demonstrated ability to deliver to timelines.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively \xe2\x80\x9cLilly\xe2\x80\x9d) 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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