Industry: Pharmaceutical 

Job Mode: 100%Remote 

Purpose: 

• The Medical Writing Word Processing Coordinator is responsible for formatting, proofing, and completion of Clinical Protocols, Clinical Study Reports, Investigator's Brochures, and other related clinical regulatory documents.  
• Provides document formatting support to Medical Writing, Clinical, and, other functional areas, 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 eSubmissions standards so that the documents created in MS Word correctly render to PDFs. 

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 at 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. 
• Accurately and timely maintain document tracking for all documents.  
• Ensures literature citations are correct.  
• Performs literature searches.  
• 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: 

• Experience Level = 3-5 Years 
• A minimum of 3 years of relevant industry experience within medical writing in a global pharma, biotech, life science, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas