The Senior Medical Writing Word Processing group provides specialized word processing services to clients across various functional areas in the company.
ResponsibilitiesProcess, proofread, verify, and manage various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency.Communicate regularly with colleagues and management regarding timelines and conflicts for word processing requests, eSubmissions issues, and document completion dates.Provide ongoing support for Medical Writing, Clinical, and other functional areas; act as a liaison between RIMS support and Medical Writing as needed.Ensure all electronic document deliverables are processed and completed in alignment with timelines.Meet the main objectives of assigned word processing projects within established timelines and with an appropriate quality level.Ensure document styles and formatting are consistent with defined eSubmissions standards, so that documents created in MS Word are correctly rendered to PDFs.Confirm formats and styles are consistent with those in the clinical regulatory templates, when applicable.Provide services and results on time, accurately, and consistent with expectations.Populate document properties and ensure correct naming conventions are used per the eSubmissions System file naming conventions.Maintain knowledge of eSubmissions styles and formatting standards.Continually train and be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.Participate in process improvement activities.Skills and QualificationsAdvanced Microsoft Word knowledgeExperience working in a document management systemExperience working with documentation in a regulated industry (e.g., pharmaceutical, legal, government)BS or BA DegreeKnowledge of Adobe Pro, including bookmarking and hyperlinking5 years of experience in a related roleWork Environment
100% Remote. Monday – Friday, 8am to 5pm (start and stop time is flexible 1 hour in either direction).
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