Medical Writing Word Processing Coordinator II

Spectraforce Technologies, Inc.; Avon (IL); Remote; USD 65,000 - 90,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Medical Writing Word Processing Coordinator II to support formatting of CSR appendices and regulatory documents in a fully remote, 12-month assignment.

You will work closely with Medical Writers and cross-functional teams to ensure documents meet formatting standards and regulatory requirements, delivering publication-ready PDFs on time. Responsibilities include defining CSR formatting scope, managing document properties in RIMS, and ensuring

Qualifications

• Bachelor of Science or degree in English or Communications will be considered.
• 3 to 5 years of relevant pharmaceutical industry experience in medical writing, quality, regulatory, clinical research, or product support/R&D desired.

Responsibilities

• Define scope of CSR formatting with the document author.
• Format, import and route documents in RIMS.
• Ensure document styles and naming follow templates in RIMS.
• Publish documents in RIMS to meet timelines.
• Maintain CSR appendices organization and CTD knowledge.
• Communicate deliverables and timelines to stakeholders.
• Train and support compliance with eSubmissions standards.

Skills

Word processing

Regulatory submissions

RIMS formatting

PDF publishing

Communication

Education

Bachelor in English/Communications

Tools

MS Word

eSubmissions system

Job description

Medical Writing Word Processing Coordinator II

Position Title: Medical Writing Word Processing Coordinator II - 100% Remote

Assignment Duration: 12 Months

Position Summary:
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.

Background & Context:
The Strategic Medical Writing Operations team supports the creation, formatting, and management of clinical and regulatory documents submitted to health authorities. This position primarily focuses on formatting existing content, document quality, and PDF submission readiness rather than writing or creating content.

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.
• 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.

Qualifications & Experience:

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