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 Bioproducts Research and Development (BRD) organization within Lilly Research Laboratories spans the drug development life cycle from candidate selection to submission and post-approval and includes chemistry, manufacturing, and control support for drug development.
The Document / Data Steward and Business Operations Support person provides support to the BRD scientist group, assisting with non-laboratory-based activities that support analytical development, characterization, testing, and documentation.
Objectives of Position
The associate provides support for IT systems and related processes that support analytical testing, development, characterization and documentation activities for process and product development, clinical trial materials, primary stability studies and technology transfers. The team supports development and implementation of new informatics tools, as well as upgrades, troubleshooting, and maintenance for existing tools in production, data and document support activities. Job responsibilities include execution and oversight of document and data steward roles for Veeva Vault QualityDocs, NuGenesis and other systems, support in creation/maintenance of critical documents, change controls, and influencing the design and development of new informatics tools.
QualityDocs Document Steward
Upload new documents into Veeva Vault QualityDocs and populate document properties
Create the QualityDocs routing notice for document approval
Monitor routing notice status (including follow up if any delay is noted) and set effective date after document approval
Follow the local standards for documentation practices and record retention
Reference and update the guidance documents
Generate process metrics as required
Respond to all phone calls, instant messages, and emails regarding QualityDocs system and process questions
Respond to all client issues regarding the collaboration site used to submit documents to be routed in QualityDocs
Notify client and/or escalate issue if appropriate document formats and conventions are not followed (e.g. Level 1 change tab usage, allowable types of INFO docs, naming conventions)
NuGenesis Data Steward
Curate NuGenesis System master data including Tests, Methods, Specification, Product entities and system List values.
Review, update, validate and document current NuGenesis interfaces (where documentation is missing or incomplete)
Design, develop, validate, document new interfaces and/or templates used with NuGenesis
Knowledge/experience with Empower and Empower custom fields is desired but not required
Business Operations Support
Support business operations for material supply and material dating documentation.
Create templates to capture information from scientists using Excel, PowerBI, and develop Sharepoint site
Create or update material specification packages and manage in QualityDocs.
Data integrity tasks.
Create and manage change controls using Trackwise software application. Utilize Trackwise or other program to assign tasks to scientists
Construct useful and intuitive dashboards enabling scientists to retrieve and visualize high frequency/high impact data quickly. Utilize dashboards to monitor progress of tasks and notify scientists of upcoming due dates
Translate and summarize scientific data from multiple data reports into a summary document or report utilizing Microsoft Word, Microsoft Excel, or an electronic notebook
Compile and track data for control charting
Perform data integrity reviews for data contained in scientific reports and tables
Develop MS Office templates to support change control documentation.
Develop data integration templates.
Bachelors or master’s degree in chemistry, pharmacy or related field with at least 3 years industrial experience
A working knowledge of laboratory techniques and analytical testing.
Experience with Trackwise, Regulus, Veeva Vault QualityDocs, NuGenesis (includes SDMS, ELN, Sample Management), Empower is desirable but not required
Proficiency with existing Microsoft products and platforms, including Excel, Word, Sharepoint, OneNote, PowerBI, Powerapps.
Ability to summarize technical information, including data, into a written format
Excellent communication skills: the candidate will work directly with multiple scientists
Organizational skills: the candidate will handle multiple tasks daily and track to ensure tasks are completed.
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.