Clinical Word Processing Coordinator - REMOTE

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.

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