Medical Writing Coordinator/Publisher I
Core
Coordinate, format, and publish clinical study reports (CSR) and regulatory documents to ensure compliance and support drug development submissions.
Role type
Medical Writing Coordinator / Publisher
Builds
Clinical Study Reports (CSR), CSR Appendices, and regulatory submissions (eCTD)
Domain
Pharmaceutical / Biotechnology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing operations, Clinical Study Report (CSR) structure, Common Technical Document (CTD) structure, Regulatory Information Management Systems (RIMS), Content management systems (Veeva Vault, CARA), Reference management software (EndNote), Microsoft Office Suite, Adobe software
Preferred skills
Master file system management, Agile methodologies, Training and mentoring
Technologies
RIMS, Veeva Vault, CARA, EndNote, Microsoft Office, Adobe
Responsibilities
Define scope of formatting and publishing activities, perform quality reviews, import and route documents in RIMS, ensure document consistency with templates, confirm completeness of documents (Casebooks, Literature References), contribute to process development, mentor junior staff
Seniority
Individual Contributor (IC), entry-to-mid level