Scientist III, Clinical Regulatory Writing
Core
Author, review, and edit clinical regulatory documents (CSRs, protocols, CTD summaries) for pharmaceutical and biotech clients to ensure compliance with global regulatory requirements.
Role type
Senior Clinical Regulatory Writer (Scientist III)
Builds
Regulatory submission documents and clinical study reports for pharma/biotech clients
Domain
Life Sciences / Clinical Regulatory Affairs
Required skills
Clinical Study Report (CSR) authoring, Protocol writing, CTD Module 2 summaries, ICH guidelines knowledge, GCP compliance, FDA/EMA regulatory requirements, Cross-functional collaboration, Project management
Preferred skills
Pharmaceutical industry background, Clinical drug development process expertise, Statistical Analysis Plan (SAP) review
Technologies
eCTD, Clinical development tools
Responsibilities
Author and review clinical regulatory documents including CSRs and protocols; Collaborate with Clinical Operations, Biostatistics, and Regulatory Affairs; Manage review cycles and version control; Ensure compliance with ICH, FDA, and EMA guidelines.
Seniority
Senior, hands-on IC
