Medical Writing Ops Formatter: CSR Formatting & Tracking

Planet Pharma; North Chicago (IL); On-site; USD 32,000 - 59,000; Full time

Job summary

Planet Pharma seeks a Medical Writing Operations Formatter to format and coordinate CSR Appendices, ensuring consistency with regulatory templates and RIMS standards. You will collaborate with Medical Writers and cross-functional teams to deliver submission-ready documents on schedule.

The role requires a Bachelor’s in English or Communications and 3–5 years of pharmaceutical writing/regulated document experience, with strong MS Word and eSubmissions knowledge. On-site role in the United States.

Qualifications

• Processes, proofs, verifies and manages regulatory documents for submission.
• Communicates timelines and conflicts regarding word processing requests.
• Maintains knowledge of eSubmissions styles and formatting standards.
• Trains and remains compliant with industry requirements for submissions.
• Acts as liaison between eDocs support and Medical Writing.

Responsibilities

• Defines scope of CSR Appendix activities with the document author.
• Format, import and route documents in RIMS.
• Ensure formatting and styles align with CSR and regulatory templates.
• Maintain document properties and naming conventions.
• Publish documents in RIMS and meet timelines.
• Coordinate CSR Appendices within regulatory information systems.

Skills

Document formatting

CSR appendices knowledge

RIMS familiarity

MS Word proficiency

Communication & collaboration

Education

Bachelor's degree in English or Communications

Tools

RIMS

eSubmissions System

Master file system

MS Word

Job description

Planet Pharma seeks a Medical Writing Operations Formatter to format and coordinate CSR Appendices, ensuring consistency with regulatory templates and RIMS standards. You will collaborate with Medical Writers and cross-functional teams to deliver submission-ready documents on schedule.

The role requires a Bachelor’s in English or Communications and 3–5 years of pharmaceutical writing/regulated document experience, with strong MS Word and eSubmissions knowledge. On-site role in the United States.