Processes, proofreads, verifies and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency.
Communicates regularly with colleagues and management regarding timelines and conflict to timelines for word processing requests, Submissions issues, and document completion dates.
Provides ongoing support for Medical Writing, Clinical, and other functional areas; acts as a liaison between RIMS support and Medical Writing as needed.
Responsible for effective communication among team members.
Ensures all electronic document deliverables are processed and completed in alignment with timelines.
Accountable for meeting the main objectives of assigned word processing projects within established timelines and with an appropriate quality level.
Ensures document styles and formatting are consistent with defined Submissions standards, so that documents created in MS Word are correctly rendered to PDFs.
Confirms formats and styles are consistent with those in the clinical regulatory templates, when applicable.
Accountable for providing services and results on time, accurately and consistent with expectations.
Populates document properties and ensures correct naming conventions are used per the Submission System file naming conventions.
Maintains knowledge of Submissions styles and formatting standards.
Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.
Participates in process improvement activities.
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).