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.
Requirements
Master’s degree in scientific, health, communications, or technology related field.
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.