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're looking for people who are determined to make life better for people around the world.
Purpose: The purpose of the Specialist, GSC Document Delivery Hub LCCI role is to support the Global Scientific Communications team and other functions to produce documents of high quality.
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. Scientific Communications Document Support
Ensure timely delivery of error-free, high-quality documents that meet international standards of written English

• Perform quality review of regulatory and publication documents developed by medical writers.
• Correct errors in grammar, style, formatting, and syntax. Identify and fix flaws in logic and flow
• Follow style guides/templates provided by the team
• Follow best-practice based on Lilly internal standards
• Verify data against source files, ensure accuracy and consistency of data and content within and between related documents

Document finalization/publishing services

• Produce final eCTD-compliant PDFs of medical regulatory documents using publishing software
• Review and format Word files to ensure as many compliance requirements are in the source file as possible
• Render the Word files into PDFs
• Review the PDFs and edit them as needed to ensure that all regulatory requirements are met

Document Management

• Launch shells and manage document metadata
• Support scientists and other functions with processing publications through steps such as editing, data integrity review, approval and submission to specified venues. Track status, milestones & associated documentation
• Manage Datavision, including data steward/project management responsibilities
• Support encoring efforts across therapy areas, functions and regions, by editing, adapting word counts per venue guidelines and completing other steps in the publications procedure, as required
• Conduct literature searches, obtain and process copyright transfer and authorship agreements; verify data and references for accuracy; create figures and diagrams, write cover letters to journal editors and coordinate and/or conduct translation and/or validation, ensure all steps of the submission process are executed
• Write regulatory and publication documents to support Global Scientific Communications' workload

General expectations

• Maintain a strong customer focus
• Accountable for achieving timelines by managing activities efficiently and proactively; utilize ability to understand and apply team communication strategies to work products
• Coach new Specialists or others requiring development in core areas
• Coordinate with vendors if any of the aforementioned activities are outsourced

2. Process efficiency and technology advancement

• Maintain proficiency in applicable software, tools, processes, and workflows
• Use creativity to introduce new tools, processes, and structure to accomplish broader organizational goals and meet standards while providing solutions to streamline team workflow
• Improve document processes by establishing uniform cross-organizational practices; suggest process or tool enhancements to improve effectiveness and minimize redundancy between databases and other tools

3. Therapeutic & Disease State Management

• Understand key priorities and communication strategies across therapeutic areas and/or organizational units
• Maintain a working knowledge of product and disease state information
• Continue to develop therapeutic knowledge and be familiar with trial design, rationale and data. Apply this knowledge in activities listed above

Minimum Qualification Requirements:

• Bachelor's degree
• Strong written and verbal communication skills in English
• Demonstrated ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues, external vendors and customers
• Demonstrated project management and time management skills
• Cognitive abilities, including verbal reasoning, attention to detail, critical thinking, and analytical ability
• Interpersonal skills and the ability to be flexible in varying environments
• Ability to utilize high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates)
• Ability to work well independently and as part of a team, within and across culturally and geographically diverse environments
• Proven ability to assemble, share and apply key learnings across multiple projects

Other Information/Additional Preferences:

• Specialized knowledge of editing & proofreading techniques
• Knowledge of medical and statistical terminology; willingness to expend effort in acquiring scientific knowledge and understand strategic issues
• General knowledge of scientific literature search and retrieval
• Limited travel, up to approximately 10%

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 ( ) 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.
#WeAreLilly

Skills Required