Medical Writing Word Processing Coordinator II

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

Pay range: 23-43/hr
*depending on experience

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.