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

Qualifications :

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):

• Bachelors degree in Life Sciences Technical Communication English or related discipline; Masters preferred.
• 46 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.

Additional Information :

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 CVs and cover letters will be reviewed however please note that we are not always able to respond to every expression of interest submitted.  

Remote Work :

No

Employment Type :

Full-time