PLM Data Steward for SMDD vTeam
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.
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. Our 34,000 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 are looking for people who are determined to make life better for people around the world.
The Synthetic Molecule Design and Development (SMDD) Organization within the Lilly Research Labs is an integrated synthetic molecule drug development organization which spans drug discovery and development phases from early discovery to submission and post-approval.
Candidates must demonstrate a history of strong technical depth, data management, and a willingness to promote a collaborative, team-based approach to problem solving. The candidate will have working fundamental knowledge of Product Lifecycle Management (PLM) systems capabilities and value, along with demonstrated ability to apply these skills to maximize value from a PLM system to the Virtual CMC Team (vTeam) within SMDD.
Top candidates for this role will be expected to:
Design, develop, and apply data requirements, workflows, and metrics within PLM software to support early phase synthetic molecule design and development
Contribute to vTeam operational effectiveness by enabling full utilization of the PLM software to speed early clinical product development and supply chain
Promote general research and development effectiveness and productivity enhancement through application and analysis of information monitoring / metrics from the vTeam PLM system
Demonstrate the ability to work independently, or more frequently, as part of a product development team consisting of Chemists, Engineers, Formulation Scientists, analysts, program managers, and Quality Assurance
Be an advocate and thought leader for data, educating the vTeam on PLM capabilities and keeping a pulse on new best practices and technology
Assure quality and trust in the data, create standard definitions for the organization to follow, and maintain a consistent use of data resources across the vTeam
Be a trusted resource that ensures data integrity is aligned with the Quality System and regulatory requirements
The data steward will carry out six key responsibilities:
Define the data and identify assets within data object domains. Ensure there are no conflicts with other data elements.
Create processes and procedures to monitor adherence. This includes establishing internal policies and standards—and enforcing those policies.
Maintain quality of the data using customer feedback, quality system expectations, regulatory requirements (data integrity); internally reporting metrics; evaluating and identifying issues; and coordinating and implementing corrections regularly.
Optimize workflows and communications.
Monitor data usage to assist teams, share best practice trends in data use, and provide insight into how and where teams can use data to help in day-to-day decision-making.
Ensure compliance and security of the data. Data stewards are responsible for protecting the data—while providing information on potential risks and offering regulatory guidance.
B.S./M.S. in Computer Sciences/Information Technology with 2-5 years of Product Lifecycle Management (PLM) experience related to pharmaceuticals, electronics, software and/or automotive/aerospace product development.
Delivered innovative solutions across the value chain in pharmaceutical product development from ideation to development to material supply and distribution
Have a proven record of providing consulting services on design, implementation, and management of product lifecycle management solutions
Brought innovative thinking to the workplace and used it to improve knowledge management systems, business processes and interactions
Successfully worked in a team environment via a remote setting
Experience working in an GxP environment, preferably Pharmaceutical or Medical Device
Limited international travel (2 – 4%) will be required
Work hours flexibility to accommodate collaboration across multiple time zones
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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-13672.
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.
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