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.

Abilities and/or Skills:

• Honest, Dependable, Demonstrated Ability to Self-Manage
• Detail Oriented, Accurate, Precise
• Strong Math Skills
• Strong Organizational Skills
• Logical Thinking, Good Reasoning Ability
• Strong communication including verbal, writing, and presentation skills
• Dedication to quality, ethics, and customer service
• Ability to handle personal stress
• Mental and emotional stability and maturity
• Motivation to excel 

All candidate CV's and cover letter's will be reviewed, however please note that we are not always able to respond to every expression of interest submitted.