Medical Writing Publisher

Roles & Responsibilities
• Support Medical Writing activities including appendices collation, peer review, QC, and document publishing for assigned projects
• Assist in preparation of study-related documents such as Study Protocols, Clinical Study Reports (CSRs), and Patient Narratives
• Prepare Clinical Study Report Appendices as per ICH E3 Section 16
• Support publishing of documents within the Medical Writing department and cross-functional teams as per agreed processes
• Track timelines and communicate document status to Medical Writers, Project Managers, and Clients
• Assist in document review and QC activities within Medical Writing
• Ensure compliance with Fortrea or Sponsor SOPs, ICH-GCP, and applicable regulatory guidelines
• With guidance from senior staff, prioritize preparatory tasks and ensure deadlines are met
• Perform additional duties as assigned to support project delivery

Qualification
• Bachelor’s degree in Biomedical / Life Sciences or related discipline
• Relevant and equivalent experience may be considered in lieu of formal education

Experience
• 2–3 years of relevant experience or equivalent combination of education and experience
• Prior experience as a Publisher within a Medical Writing or Clinical department for national or multinational studies

Skills
• Strong understanding of clinical research documentation and publishing processes
• Knowledge of ICH-GCP and regulatory requirements
• Excellent written and verbal communication skills in English
• Good organizational, coordination, and time-management skills
• Ability to manage multiple tasks and meet timelines

Work Environment
• Home-based / remote working environment
• Ability to work on a computer for extended periods (6–8 hours)
• Regular sitting and use of hands for keyboard and document handling
• Adequate visual and auditory capability to meet job requirements

About the Organization
Fortrea – A leading global provider of clinical development and patient access solutions, offering opportunities to work on global clinical research projects in a flexible, remote work environment.