Medical Writing Coordinator – Publisher II

Job reputed company: • Responsible for the formatting, report publishing and coordination of the Clinical Study Reports (CSR) Appendices for clinical and regulatory documents. • Collaborates with the document author and tracks activities and performs detailed reputed company reviews. • Imports and routes documents in the regulatory information management systems (RIMS). • Formats documents to the defined styles and confirms consistency with the clinical and regulatory templates. • Ensures the RIMS document properties and naming conventions are followed. • Maintains strong knowledge of RIMS styles and formatting standards. • Publishes documents in RIMS and maintains strong knowledge of RIMS system and publishing tools/software. • Coordinates the CSR Appendices and confirms completeness of documents (e.g. Casebooks, Literature References) by obtaining, compiling, and organizing in the RIMS. • Maintains strong knowledge of CSR and CSR Appendices and CTD structure. • Contributes to the development, implementation, and maintenance of medical writing operations business processes. • Acts as subject matter expert (SME) for the master file system and formatting report publishing and CSR Appendices to the strategic medical writing stakeholders. • Effectively communicates deliverables needed to stakeholders. • Must demonstrate good interpersonal and organizational communication skills, including conflict management skills. • Assists in the management of the centralize mailbox. • Tracks and maintains metrics and assists in the preparation and maintenance of training documents. • Mentors and provides guidance and training to less senior strategic medical writing operations staff members. Requirements: • A minimum of 4 years of relevant industry experience reputed company medical writing in a global reputed company, biotech, life science, or federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas • High School diploma required • Background of organization and content of clinical documents and eCTD structure • Knowledge of drug development and experience with Common Technical Document (CTD) content templates • Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas • Detail-oriented with a commitment to delivering high-reputed company, accurate and compliant documentation • Strong communication, collaboration, and organizational skills • Ability to interpret statistical analyses of clinical data • Ability to work independently and as part of reputed company Benefits: • Medical/dental/reputed company insurance • 401(k) to eligible employees • reputed company time off (vacation, holidays, reputed company) • Short-term incentive programs Apply tot his job Apply To this Job