Medical Writing Word Processing Coordinator

Wall Street Consulting Services LLC; Illinois; Remote; USD 80,000 - 110,000; Full time

Job summary

Wall Street Consulting Services LLC is seeking a Medical Writing Word Processing Coordinator to support formatting of Clinical Study Reports (CSR) and CSR Appendices remotely. The role collaborates with Medical Writers and cross-functional teams to ensure submission-ready documents meet regulatory standards and timelines.

Responsibilities include formatting, reviewing, and coordinating CSR Appendices within RIMS, while maintaining document properties, templates, and publishing to PDFs.

Qualifications

• 5+ years of pharma industry experience in medical writing or regulatory support.
• Experience formatting CSR appendices and eSubmissions.
• Strong knowledge of regulatory templates and CTD structure.

Responsibilities

• Defines scope of formatting for CSR Appendices in collaboration with document author.
• Format, import and route documents in RIMS; ensure consistency with templates.
• Publish documents in RIMS and ensure timely delivery; maintain CSR Appendices information.

Skills

5+ years pharma exp

MS Word

RIMS

Education

Bachelor of Science or BA in English/Communications

Tools

MS Word

Regulatory Information Management System (RIMS)

Job description

Position Title: Medical Writing Word Processing Coordinator

Location: Remote

Contract Period: 12 Months

Shift Timings: Mon - Fri, 08:00 AM - 05:00 PM CST

MUST HAVE 5+ YEARS OF PHARMACEUTICAL INDUSTRY EXP.

Remote

Length of assignment: 1 year

• The Medical Writing Operations Formatter provides document formatting and Clinical Study Report (CSR) Appendix support for clinical and regulatory documents.
• This role partners closely with Medical Writers and cross-functional stakeholders to ensure documents meet established formatting standards, regulatory requirements, and project timelines.
• The formatter is responsible for formatting, reviewing, and maintaining high-quality submission-ready documents and supporting CSR Appendix coordination activities within Regulatory Information Management Systems (RIMS).

Key Responsibilities

• Defines scope of formatting, or Clinical Study Reports (CSR) Appendices activities with the document author.
• Format, import and route documents in the regulatory information management systems (RIMS).
• Ensure document format and styles are consistent with the defined in RIMS and are consistent with the clinical and regulatory templates.
• Ensure document properties and naming conventions are used.
• Maintain strong knowledge of RIMS styes and formatting standards.
• Ensures all documents are published in RIMS and meet required timelines.
• Ensure completeness of information in CSR Appendices.
• Maintain strong knowledge of CSR/CSR appendices organization and content and knowledge of CTD structure.
• Contributes to the development, implementation, and maintenance of medical writing operations business processes.
• Acts as subject matter expert (SME) for the master file system and formatting, report publishing, or Clinical Study Reports (CSR) Appendices to the medical writing stakeholders.
• Effectively communicates deliverables needed to stakeholders.
• Must demonstrate good interpersonal and organizational communication skills, including conflict management skills.
• Assists in the management of the centralized mailbox.
• Tracks and maintains metrics and assists in the preparation and maintenance of training documents.

Responsibilities/Qualifications:

• 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 with 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 maintains 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.
• Bachelor of Science or Bachelor's degree in English or Communications will be considered.
• 3 to 5 years of relevant pharmaceutical industry experience in a related area such as medical writing, quality, regulatory, clinical research, or product support/Research & Development desired.