Katalyst Healthcares & Life Sciences
Location: Waukegan,IL, USA
Date: 2024-12-17T23:35:14Z
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).