Scientist III, Clinical Regulatory Writing
Core
Author, review, and edit clinical regulatory documents (CSRs, protocols, CTD summaries) for pharmaceutical and biotechnology 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
Pharmaceutical/Biotechnology Regulatory Affairs
Required skills
Clinical Study Report (CSR) authoring, Clinical Protocol writing, CTD Module 2 summaries, ICH guidelines knowledge, GCP compliance, FDA/EMA regulatory requirements, cross-functional collaboration, project management, scientific data interpretation
Preferred skills
PharmD or PhD, background in pharma/clinical/scientific areas, experience in CRO industry
Technologies
eCTD, Clinical Study Reports, Investigator Brochures, Briefing Books
Responsibilities
Author and review clinical regulatory documents including CSRs and protocols; Contribute scientifically to study teams on regulatory requirements; Collaborate with Clinical Operations, Biostatistics, and Regulatory Affairs; Plan data analysis presentation strategies for CSRs; Manage review cycles and version control; Serve as SME on global regulatory guidelines
Seniority
Senior, hands-on IC
