Medical Writing Word Processing Coordinator II - Regulatory Document Formatting and CSR Appendices

Orion Group; United States; Remote; USD 83,097,000 - 100,124,000; Full time

Job summary

Orion Group is seeking a Medical Writing Operations Formatter to provide document formatting and CSR appendix coordination for regulatory submissions. This remote role supports Medical Writing and Regulatory Information Management Systems.

You will apply Word styles, format CSR appendices, verify literature citations, and ensure documents meet templates and deadlines across functional teams.

Qualifications

• Knowledge of Microsoft Word styles and regulatory document formatting standards.
• Knowledge of CSR and CSR appendix organization and content, including CTD structure.
• Knowledge of RIMS and eSubmissions styles, document processing, publishing, and file naming conventions.

Responsibilities

• Define the scope of document formatting or CSR appendix activities with the document author.
• Process, proofread, verify, and manage clinical regulatory documents to ensure submission readiness.
• Format, import, route, and publish documents in RIMS within required timelines.
• Apply RIMS and eSubmissions styles and formatting standards.
• Populate document properties and apply correct RIMS/eSubmissions naming conventions.
• Ensure CSR appendices contain complete information and support coordination and content.
• Communicate deliverables, timelines, completion dates, issues, and conflicts to stakeholders.
• Provide ongoing support to Medical Writing and related teams; liaise between eDocs support and Medical Writing.
• Serve as SME for master file system, formatting, and report publishing for Medical Writing stakeholders.
• Verify literature citations and perform literature searches.
• Contribute to development and maintenance of Medical Writing Operations processes.
• Assist with centralized mailbox, metrics, and training documents.

Skills

Word styles

CSR formatting

RIMS

eSubmissions

Document publishing

Literature citation verification

Communication

Education

Bachelor of Science in English or Communications

Tools

Microsoft Word

Job description

Medical Writing Word Processing Coordinator II - Regulatory Document Formatting and CSR Appendices

Location: 100% remote. Candidates must be located in the US and able to work without visa sponsorship.

Length of Assignment: 1 year

Pay Rate: $29-35/hr (depending on benefits preference and candidate location)

Job Description

The Medical Writing Operations Formatter provides document formatting and Clinical Study Report (CSR) appendix support for clinical and regulatory documents. This role partners with Medical Writers and stakeholders across functions to ensure documents meet established formatting standards, regulatory requirements, and project timelines. The coordinator formats, reviews, and maintains high-quality, submission-ready documents and supports CSR appendix coordination within Regulatory Information Management Systems (RIMS).

• Define the scope of document formatting or CSR appendix activities with the document author.
• Process, proofread, verify, and manage clinical regulatory documents to ensure they are submission-ready, accurate, and consistent.
• Format, import, route, and publish documents in RIMS within required timelines. Ensure electronic document deliverables meet the objectives, quality expectations, and deadlines of assigned word processing projects.
• Apply RIMS and eSubmissions styles and formatting standards. Confirm consistency with clinical and regulatory templates and ensure Microsoft Word documents render correctly to PDF.
• Populate document properties and apply the correct RIMS and eSubmissions file naming conventions. Maintain accurate and timely document tracking.
• Ensure CSR appendices contain complete information and support their coordination, organization, and content.
• Communicate deliverables, word processing timelines, completion dates, eSubmissions issues, and timeline conflicts to colleagues, stakeholders, and management.
• Provide ongoing support to Medical Writing, Clinical, and other functional areas. Serve as a liaison between eDocs support and Medical Writing as needed and ensure effective communication among team members.
• Serve as a subject matter expert for the master file system and formatting, report publishing, or CSR appendices for Medical Writing stakeholders.
• Verify the accuracy of literature citations and perform literature searches.
• Contribute to the development, implementation, and maintenance of Medical Writing Operations business processes and participate in process improvement activities.
• Assist with management of the centralized mailbox, track and maintain metrics, and help prepare and maintain training documents.
• Maintain current knowledge of formatting standards and complete ongoing training to remain compliant with industry requirements for regulatory submissions, including electronic submission and approval standards.

Qualifications

• Knowledge of Microsoft Word styles and regulatory document formatting standards, including accurate rendering of Word documents to PDF.
• Knowledge of CSR and CSR appendix organization and content, including Common Technical Document (CTD) structure.
• Knowledge of RIMS and eSubmissions styles, document processing, publishing, document properties, and file naming conventions.
• Bachelor of Science or a bachelor’s degree in English or Communications will be considered.
• Three to five years of relevant pharmaceutical industry experience is desired, including related work in medical writing, quality, regulatory, clinical research, or product support/Research and Development.
• Strong proofreading and verification skills, with attention to document accuracy, consistency, and submission readiness.
• Good interpersonal, organizational, and communication skills, including conflict management and the ability to coordinate deliverables and deadlines across functions.

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