Technical Writer (GLP Studies – Product Safety Labs)

ENGLISH

Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2020, Eurofins generated 5.4 billion Euro proforma turnover in 800 laboratories across 50 countries, employing about 50.000 staff.

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.

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.

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

Requirements

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.