Medical Writing Coordinator – Publisher I

. Define the scope of formatting, report publishing, and Clinical Study Reports (CSR) Appendices activities with document authors .

Posted 9/25/2026full-timeRemote • Illinois • United StatesJuniorMid-Level💰 $58,656 - $103,500 per yearWebsite

Tools & technologies

Vault

Key responsibilities & impact

Define the scope of formatting, report publishing, and Clinical Study Reports (CSR) Appendices activities with document authors
Coordinate and track activities and perform detailed quality reviews
Import and route documents in regulatory information management systems (RIMS)
Ensure document formatting, styles, properties, and naming conventions comply with RIMS standards and clinical and regulatory templates
Publish documents in the RIMS content management system within required timelines
Maintain knowledge of RIMS and publishing tools/software
Confirm completeness of documents such as Casebooks and Literature References by compiling and organizing them in RIMS
Maintain knowledge of CSR, CSR Appendices, and CTD structure
Contribute to the development, implementation, and maintenance of medical writing operations processes
Act as subject matter expert for the master file system and formatting, report publishing, or CSR Appendices
Communicate deliverables to stakeholders
Assist with management of the centralized mailbox
Track and maintain metrics and assist with training documents
Mentor and provide guidance and training to less senior medical writing operations staff
Work requires continuous sitting for prolonged periods, more than two consecutive hours in an eight-hour day

What you’ll need

High School diploma required
Minimum of 2 years of relevant industry experience within medical writing in a global pharma, biotech, life science, or federal agency organization
Experience delivering medicines or therapies across various therapeutic areas
Knowledge of clinical document organization and content and eCTD structure
Knowledge of drug development and Common Technical Document (CTD) content templates
Outstanding written and oral communication skills
Comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas
Detail-oriented with commitment to high-quality, accurate, and compliant documentation
Strong communication, collaboration, and organizational skills
Ability to work independently and as part of a team
Proficiency with Microsoft Office products, including Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, and Word
Proficiency with Adobe in a Windows operating system environment
Proficiency with Microsoft document file formats (DocX), style file format tools, publishing software, and content management archival systems for eTMF/eSubmissions such as Veeva Vault and CARA
Proficiency with reference management software such as EndNote

Comp & perks