- Ensure timely delivery of error-free, high-quality documents that meet international standards of written English
- Correct errors in grammar, style, formatting, and syntax.
- Identify and fix flaws in logic and flow
- Follow style guides and templates provided by the team
- Follow 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 team with editing, data integrity review, approval and submission to specified venues. Track status, milestones & associated documentation
- General expectations
- Maintain a strong customer focus
- Communicate effectively
- Manage activities efficiently and proactively to achieve timelines
- Coach new Specialists or others requiring development in core areas
- Coordinate with vendors if any of the aforementioned activities are outsourced.
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.
Therapeutic and disease state management
- Understand key priorities and communication strategies across therapeutic areas and/or organizational units
- Maintain a working knowledge of product and