Position Summary:
The Technical Writer supports the preparation, revision, formatting, control, and organization of study documentation associated with GLP-compliant preclinical research. The role enables Study Directors to focus on scientific interpretation and regulatory accountability.
Essential Duties and Responsibilities:
- Prepare first drafts of study protocols using approved templates and Study Director guidance.
- Coordinate the development, review, revision, and issuance of study protocols, amendments, and associated study documentation in accordance with GLP requirements and internal procedures.
- Prepare report sections, narratives, tables, and appendices from approved source data.
- Create shell reports, templates, and standardized study documents.
- Coordinate document review cycles, comment resolution, and final issuance.
- Maintain version control and document history.
- Perform document quality reviews for consistency, formatting, references, and completeness.
- Organize study data packages for reporting, archival, and inspection readiness.
- Manage signature tracking and document routing activities.
- Collaborate with Study Directors, laboratory personnel, QA, and project teams.
- Cross-train across multiple study types to support workload demands.
- Escalate scientific interpretation or unresolved content issues to the Study Director.
- Maintain historical databases