Clinical publisher

Medical Writing Clinical Publisher The primary responsibilities of the Medical Writing Clinical Publisher (Clinical Publisher) are to ensure the formatting quality of clinical documents including but not limited to clinical study protocols, clinical study reports, investigator's brochures, and summary modules for regulatory submissions. This position requires a methodical approach to document formatting, attention to detail, advanced Word processing skills (eg, macros, templates) as well as experience with the MS Office suite of products and profound knowledge of the in-house Electronic Document Management System (EDMS). A Clinical Publisher in Global Regulatory Medical Writing (GRMW) Operations provides support to GRMW (and other departments as appropriate) in the production of submission-ready clinical research documentation in support of drug development, product registrations, and product marketing. The Clinical Publisher's primary responsibility focuses on document publishing activities, but includes assignment to initiatives and or other tasks and projects as directed. The Clinical Publisher is responsible for document formatting checks and ensures that GRMW documentation developed by medical writers adheres to applicable regulatory guidelines and departmental standards. The Clinical Publisher will be on-the-job trained to leverage the master template and add-in toolbar to ensure consistency within documents prepared by medical writing or external partners. The Clinical Publisher will be able to advise and provide guidance to medical writers regarding formatting issues and document management in the official repository as needed. The Clinical Publisher will be on-the-job trained on Client internal standard processes and systems involved with electronic document management.