Coordinator, Word Processing
The Coordinator, Word Processing is responsible for formatting, proofing, and completion of Clinical Protocols, Clinical Study Reports, Investigator's Brochures, and other related clinical documents. Provides regulatory document formatting support to the Medical Writing and Clinical teams, ensuring successful preparation of high-quality, submission-ready documents. Ensures completion of work to meet multiple client deadlines. Ensures styles and formatting are consistent with defined eSubmissions standards so that the documents created in MS Word correctly render to PDF. Proofreads documents for accuracy and consistency. Participates in process improvement activities. Key Responsibilities Include :
- Processes, proofreads, verifies and manages various Clinical documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy.
- 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 Writers and others; acts as a liaison between eDocs support and Medical Writing organization 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 format and style are consistent with defined eSubmissions format and styles, such that documents created in MS Word are correctly rendered to PDF. Confirms formats and styles are consistent with those in the clinical templates, when applicable.
- Proofreads documents for accuracy and consistency. 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 eSubmissions System File Naming Conventions.
- Accurately and timely maintains document tracking for all documents.
- Ensures literature citations are correct. Performs literature searches.
- Maintains knowledge of eSubmissions 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.
- High School Diploma or equivalent; equivalent experience considered.
- 1+ year word processing or administrative experience or equivalent.
- Strong knowledge of word processing including formatting, use of styles and templates, table formatting, cross-referencing, and bookmarking.
- Knowledge and experience with Common Technical Document (CTD) content templates.
- Experience with document checking, importation, and workflows in electronic document management systems.
- Excellent written and oral communication skills.
- Superior attention to detail.
- High level computer skills. Proficient in electronic document management system. Excellent working knowledge of software programs in Windows environment.