Eurofins seeks a Technical Writer to prepare and manage GLP-compliant study documentation for preclinical research. The role involves drafting protocols, coordinating document reviews, organizing data packages, and supporting Study Directors with regulatory compliance.
Responsibilities
Prepare first drafts of study protocols using approved templates and Study Director guidance
Coordinate development, review, revision, and issuance of protocols, amendments, and study documentation per GLP requirements
Create report sections, narratives, tables, appendices, templates, and standardized documents from source data
Manage document review cycles, version control, signature tracking, and data package organization for reporting and inspection readiness
Collaborate with Study Directors, laboratory staff, QA, and project teams; escalate scientific interpretation issues as needed
Requirements
Bachelor's degree in Life Sciences, Technical Communication, English, or related field; Master's preferred
4–6 years technical writing experience in CRO, pharmaceutical, biotechnology, or regulated environment
Experience with protocols, study reports, amendments, and document control systems preferred
Excellent writing, editing, proofreading, and formatting skills
Strong organizational, communication, and logical reasoning abilities
Detail-oriented with high accuracy and commitment to quality and ethics
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