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Senior Word Processing Coordinator

REMOTE, IL 00000

Posted: 03/20/2023 Employment Type: Contract Job Category: Medical Affairs Job Number: 553681 Is job remote?: No Country: United States

Job Description

Title: Senior Word Processing Coordinator


The Clinical Word Processing group provides specialized word processing services to clients across various functional areas in the company. The Senior Word Processing Coordinator is responsible for formatting regulated clinical documents to ensure they comply with company standards and strict industry requirements, importing documents into the Regulatory Information Management system (RIMS) [i.e., electronic document management system], ensuring documents have the correct RIMS metadata and properties assigned, and verifying that documents correctly render from Word to PDF in the system. Other responsibilities include providing RIMS business support, troubleshooting issues in Word, and bookmarking/hyperlinking PDFs in Adobe Pro.

Must have:
  • 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)

We are open to fully remote candidates; candidates local to Lake County may be required to be onsite a certain number of days a week. It will be an initial 6 month contract with potential to extend.

Description: The Senior Word Processing Coordinator II is responsible for formatting, proofing, and completion of clinical protocols, clinical study reports, investigator brochures, summaries, and other related clinical documents. Provides regulatory document formatting support to the Medical Writing, Clinical, and Pharmacovigilance 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 eSubmission standards so that the documents created in MS Word correctly render to PDF. Proofreads documents for accuracy and consistency. 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.

Responsibilities: 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, 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. 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 eSubmissions 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 eSubmissions System file naming conventions. 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.

Qualifications: 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.
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