Technical Writer (GLP Studies - Product Safety Labs) in Bangalore, भारत

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