Clinical Word Processing Coordinator - REMOTE

ProClinical 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.

Job Responsibility:

  • 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

Similar jobs near me

Related articles