Medical Writing Ops Formatter: CSR Formatting & Publishing

Us Tech Solutions; North Chicago (IL); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

US Tech Solutions is seeking a Medical Writing Operations Formatter to support formatting and CSR Appendix activities for regulatory documents. This role works with Medical Writers and cross-functional teams to ensure submission-ready documents meet formatting standards and timelines.

Responsibilities include handling CSR appendices, using RIMS and eSubmissions, maintaining document properties and styles, and communicating deliverables to stakeholders.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Document formatting

Regulatory documentation

Stakeholder communication

Conflict management

Formation

Bachelor's degree in English or Communications

Outils

MS Word

RIMS

eSubmissions System

Description du poste

US Tech Solutions is seeking a Medical Writing Operations Formatter to support formatting and CSR Appendix activities for regulatory documents. This role works with Medical Writers and cross-functional teams to ensure submission-ready documents meet formatting standards and timelines.

Responsibilities include handling CSR appendices, using RIMS and eSubmissions, maintaining document properties and styles, and communicating deliverables to stakeholders.