Clinical Word Processing Coordinator - REMOTE
word processing coordinator remote medical regulatory writing word processing management ms word research adobe document management management system
March 16, 2023
North Chicago, USA
Proclinical is seeking a remote Clinical Word Processing Coordinator for a top pharmaceutical company.
Must be eligible to work or be a citizen in the US.
- Processes, proofreads, verifies, and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency.
- Provides regulatory document formatting support to the Medical Writing, Clinical, and Pharmacovigilance Teams, ensuring successful preparation of high-quality submission-ready documents.
- Ensures styles and formatting are consistent with defined eSubmission standards so that the documents created in MS Word correctly render to PDF.
- Coordinates and communicates with other word processing team members for consistency for all documents. Imports and routes documents in the submission system ensuring proper naming conventions and document properties.
- Communicates regularly with colleagues and management regarding timelines and conflict to timelines for word processing requests, eSubmissions issues, and document completion dates.
- Provides ongoing support for Medical Writing, Clinical, and other functional areas; acts as a liaison between eDocs support and Medical Writing as needed.
- Ensures all electronic document deliverables are processed and completed in alignment with timelines.
- Confirms formats and styles are consistent with those in the clinical regulatory templates, when applicable.
- Populates document properties and ensures correct naming conventions are used per the eSubmissions System file naming conventions.
- Maintains knowledge of eSubmissions styles and formatting standards.
- Participates in process improvement activities.
Skills and Requirements:
- Bachelor of Science or Bachelor's degree in English or Communications will be considered.
- 5+ years relevant pharmaceutical industry experience in a related area such as medical writing, quality, regulatory, clinical research, or product support/Research & Development desired.
- Advanced Microsoft Word knowledge (e.g., TOC building, cross referencing, table formatting, and troubleshooting skills).
- Knowledge of Adobe Pro, including bookmarking and hyperlinking.
- MS Word certification .
- Experience working in a document management system.
- Experience working with documentation in a regulated industry (e.g., pharmaceutical, legal, government).
- Proficiency in Adobe and ISI toolbox, experience working in a document management system; knowledge of Common Technical Document (CTD) format.
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or [email protected]
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Report this job