Medical Writing Word Processing Coordinator II

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Medical Writing Word Processing Coordinator II
Location: Remote
Duration: Long Term

Job Overview

We are seeking a Medical Writing Word Processing Coordinator II to format, proofread, review, and manage clinical and regulatory documents for submission. The role involves Clinical Study Report (CSR) appendix support, document publishing, regulatory formatting standards, and coordination with Medical Writing and cross-functional teams to ensure accurate, submission-ready documents.

Key Responsibilities

• Format, proofread, review, and process clinical and regulatory documents.
• Support Clinical Study Report (CSR) appendix preparation and coordination.
• Import, format, and route documents within Regulatory Information Management Systems (RIMS).
• Ensure consistent document styles, templates, properties, and naming conventions.
• Verify document formatting and ensure accurate conversion from Microsoft Word to PDF.
• Ensure documents meet electronic submission standards and regulatory requirements.
• Review CSR appendices for completeness and accuracy.
• Maintain knowledge of CSR structure, appendix organization, and Common Technical Document (CTD) requirements.
• Verify literature citations and perform literature searches as needed.
• Track document deliverables, timelines, metrics, and completion status.
• Coordinate with Medical Writing, Clinical, Regulatory, and eDocs support teams.
• Communicate project timelines, delays, and document requirements to stakeholders.
• Support centralized mailbox management, training documentation, and process improvement activities.

Required Qualifications

• Bachelor's degree in Science, English, Communications, or a related field.
• 3 5 years of relevant pharmaceutical industry experience in medical writing, regulatory affairs, quality, clinical research, or R&D support.
• Strong experience with Microsoft Word document formatting and proofreading.
• Knowledge of clinical and regulatory documents, CSR appendices, and CTD structure.
• Familiarity with RIMS, eSubmissions systems, and electronic document publishing.
• Understanding of regulatory submission formatting standards and document naming conventions.
• Strong attention to detail, accuracy, and document management skills.
• Excellent written communication, organizational, and interpersonal skills.
• Ability to manage multiple requests, meet deadlines, and coordinate with cross-functional teams.
• Experience with document tracking, metrics, training documentation, and process improvement is beneficial.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.