Technical Writer (GLP Studies – Product Safety Labs)

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

Basic Minimum Qualifications (BMQ): To perform this job successfully, the individual must be able to perform each essential duty satisfactorily.

The requirements below are representative of the knowledge, skill or ability required.

Education/Experience (BMQ): Bachelor’s degree in Life Sciences, Technical Communication, English, or related discipline; Master’s preferred. 4–6 years of technical writing experience in a CRO, pharmaceutical, biotechnology, or regulated environment.

Experience with protocols, study reports, amendments, and document control systems preferred.

Excellent writing, editing, proofreading, and formatting skills.