Scientist II, Clinical Regulatory Writing
Core
Authoring and reviewing clinical regulatory documents including Clinical Study Reports (CSRs), protocols, and CTD summaries for pharmaceutical and biotechnology clients.
Role type
Clinical Regulatory Writer
Builds
Regulatory submission documents and clinical development reports
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Clinical regulatory writing, Clinical Study Report (CSR) authoring, Protocol writing, CTD Module 2 summarization, Clinical data interpretation, Document management tools proficiency
Preferred skills
None stated
Technologies
Veeva, MS Office
Responsibilities
Author, review, and edit clinical regulatory documents; Ensure documents meet regulatory requirements and quality standards; Incorporate reviewer feedback and manage version control; Document project timelines
Seniority
Mid-level IC
