Medical Writing Coordinator – Publisher I

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

📋 Description

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

• Oversee and monitor activities while conducting thorough quality reviews.

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

• Ensure that document formats, styles, properties, and naming conventions adhere to RIMS and clinical/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 like Casebooks and Literature References by compiling and organizing them in RIMS.

• Maintain expertise in CSR, CSR Appendices, and the structure of the Common Technical Document (CTD).

• Contribute to the development, implementation, and maintenance of medical writing operations processes.

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

• Communicate deliverables effectively to stakeholders.

• Assist in managing the centralized mailbox.

• Track, maintain metrics, and support the creation of training documents.

• Mentor and provide guidance to less experienced medical writing operations staff.

⛳️ Requirements

• A High School diploma is mandatory.

• At least 2 years of relevant experience in the industry, specifically in medical writing within a global pharmaceutical, biotech, life science, or federal agency setting.

• Familiarity with the organization and content of clinical documents and the eCTD structure.

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

• Excellent written and verbal communication skills.

• In-depth knowledge of medical and scientific terminology across various therapeutic areas.

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

• Strong skills in communication, collaboration, and organization.

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

• Proficiency in Microsoft Office applications and Adobe software on a Windows operating system.

• Expertise in Microsoft document file formats (DocX), style file format tools, publishing software, and content management archival systems for eTMF/eSubmissions (such as Veeva Vault, CARA).

• Familiarity with reference management software like EndNote.

• Capacity to sit for extended periods (more than 2 consecutive hours in an 8-hour workday).

🏝️ Benefits

• Paid time off, including vacation days, holidays, and sick leave.

• Comprehensive medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Opportunities for mentoring and training.

• Availability for remote work.