Remote Medical Writing CSR Formatter

Wall Street Consulting Services LLC; Illinois; À distance; USD 80 000 - 110 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

5+ years pharma exp

MS Word

RIMS

Formation

Bachelor of Science or BA in English/Communications

Outils

MS Word

Regulatory Information Management System (RIMS)

Description du poste

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.