Medical Writing Coordinator – Publisher I

This is a fully remote position, open to applicants in Illinois.

📋 Description

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

• Coordinate and monitor activities while conducting thorough quality reviews.

• Import and route documents within regulatory information management systems (RIMS).

• Ensure that document formatting, styles, properties, and naming conventions adhere to RIMS standards and clinical as well as regulatory templates.

• Publish documents in the RIMS content management system within specified timelines.

• Stay updated on RIMS and publishing tools/software.

• Verify the completeness of documents such as Casebooks and Literature References by compiling and organizing them in RIMS.

• Maintain expertise in CSR, CSR Appendices, and CTD structure.

• Contribute to the creation, implementation, and maintenance of medical writing operational processes.

• Serve as a subject matter expert for the master file system and formatting, report publishing, or CSR Appendices.

• Communicate deliverables effectively to stakeholders.

• Assist in managing the centralized mailbox.

• Track and maintain metrics while aiding in the preparation of training documents.

• Mentor and provide guidance and training to junior medical writing operations staff.

• The role requires prolonged periods of continuous sitting, exceeding two consecutive hours within an eight-hour workday.

⛳️ Requirements

• A High School diploma is mandatory.

• At least 2 years of pertinent industry experience in medical writing within a global pharmaceutical, biotech, life sciences, or federal agency organization.

• Experience in delivering medicines or therapies across diverse therapeutic areas.

• Familiarity with clinical document organization and content, as well as eCTD structure.

• Understanding of drug development processes and Common Technical Document (CTD) content templates.

• Exceptional written and verbal communication skills are essential.

• Extensive knowledge of medical and scientific terminology across various therapeutic areas.

• Detail-oriented with a strong commitment to producing high-quality, accurate, and compliant documentation.

• Excellent communication, collaboration, and organizational capabilities.

• Ability to work autonomously as well as collaboratively within a team.

• Proficiency in Microsoft Office applications, including Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, and Word.

• Proficient in using Adobe software within a Windows operating system environment.

• Familiarity 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.

• Proficient with reference management software like EndNote.

🏝️ Benefits

• Paid time off for vacation, holidays, and sick leave.

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Opportunity to participate in short-term incentive programs.

• Equal opportunity employer status.

• Reasonable accommodations for applicants from the US and Puerto Rico.