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Katalyst Healthcares & Life Sciences is hiring: Medical Writing Word Processing

Katalyst Healthcares & Life Sciences
Waukegan, IL Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 6/2/2025

Job Description

Job Description

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, 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).
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