Technical Writer (GLP Studies – Product Safety Labs)
Core
Prepare, revise, format, and control GLP-compliant preclinical study documentation (protocols, reports, amendments) to support regulatory accountability and enable Study Directors to focus on scientific interpretation.
Role type
Technical Writer (GLP Studies)
Builds
Study protocols, study reports, amendments, and standardized study documents for preclinical research.
Domain
Life Sciences / Preclinical Research / GLP Compliance
Required skills
Technical writing, editing, proofreading, formatting, document control, version management, data organization, quality review, template creation
Preferred skills
Experience with protocols and study reports, knowledge of document control systems, cross-training across study types
Technologies
Document control systems, template tools
Responsibilities
Prepare first drafts of study protocols, coordinate document review cycles and final issuance, maintain version control and document history, organize study data packages for inspection readiness, manage signature tracking and document routing, perform document quality reviews, maintain historical databases
Seniority
Mid-level, hands-on IC
