AbbVie
AbbVie
AbbVie is a global pharmaceutical company focused on discovering, developing, and delivering medicines for complex health conditions. Its portfolio spans immunology, oncology, neuroscience, and aesthetics, with operations serving patients in more than 175 countries. The company’s work combines pharmaceutical research, manufacturing, and healthcare expertise, supported by substantial investment in scientific innovation and research and development. AbbVie also highlights diversity, sustainability, and patient support as part of its broader approach to improving health outcomes and community impact.

Medical Writing Coordinator / Publisher I – AbbVie (Remote, Illinois)

Support AbbVie’s clinical and regulatory document publishing for innovative medicines. Manage RIMS workflows, CSR appendices, quality reviews, and medical writing operations.

Description

  • Define the scope of formatting, report publishing, and Clinical Study Report (CSR) appendix work with document authors
  • Coordinate assignments, monitor progress, and conduct detailed quality reviews
  • Import and route documents through regulatory information management systems (RIMS)
  • Ensure formatting, styles, properties, and file names meet RIMS standards and clinical and regulatory templates
  • Publish documents in the RIMS content management system within established timelines
  • Maintain working knowledge of RIMS and document publishing tools
  • Compile and organize Casebooks, Literature References, and similar materials in RIMS to verify document completeness
  • Maintain knowledge of CSR, CSR appendix, and Common Technical Document (CTD) structures
  • Help develop, implement, and maintain medical writing operations processes
  • Serve as a subject matter expert for the master file system, formatting, report publishing, or CSR appendices
  • Communicate deliverables and status updates to stakeholders
  • Support administration of the centralized mailbox
  • Track operational metrics and help maintain training materials
  • Mentor, guide, and train less experienced medical writing operations staff
  • Remain seated continuously for prolonged periods exceeding two consecutive hours during an eight-hour workday

Requirements

  • A high school diploma is required
  • At least two years of relevant medical writing experience in a global pharmaceutical, biotechnology, life sciences, or federal agency organization
  • Experience supporting the delivery of medicines or therapies across multiple therapeutic areas
  • Knowledge of clinical document organization, content, and electronic Common Technical Document (eCTD) structure
  • Knowledge of drug development and Common Technical Document (CTD) content templates
  • Excellent written and verbal communication skills
  • Broad knowledge of medical and scientific terminology across multiple therapeutic areas
  • Strong attention to detail and a commitment to accurate, high-quality, compliant documentation
  • Strong communication, collaboration, and organizational abilities
  • Ability to work independently and collaboratively
  • Proficiency with Microsoft Office applications, including Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, and Word
  • Proficiency with Adobe software in a Windows operating system environment
  • Proficiency with Microsoft document formats such as DocX, style-file tools, publishing software, and content management and archival systems for eTMF/eSubmissions, including Veeva Vault and CARA
  • Proficiency with reference management software such as EndNote

Benefits

  • Paid vacation, holiday, and sick leave
  • Medical, dental, and vision insurance
  • 401(k) plan
  • Eligibility for short-term incentive programs
  • Equal opportunity employer
  • Reasonable accommodation available for applicants in the United States and Puerto Rico

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