Safety Narrative Writer

Responsibilities

• Write, edit, review, finalize, and track clinical study report (CSR) patient safety narratives
• Serve as the primary contact for narrative writing for assigned studies and deliverable timelines
• Prepare clear and accurate narratives based on Clinical and Safety Database outputs
• Ensure medical cohesiveness, high quality, and appropriate formatting of all narratives
• Perform final quality control checks and participate in process improvement activities

Requirements

• Bachelor's or Master's degree in biomedical or life sciences fields
• 2-5 years of experience working with clinical documentation and data
• Prior experience in pharmaceutical, biotechnology, or contract research organizations (CRO)
• Knowledge of global regulations and guidelines (FDA, ICH) regarding the drug development process
• Understanding of electronic Common Technical Document (eCTD) requirements
• Proven capability to write concise, accurate, and unambiguous medical text and synopses
• Proficiency with electronic document management systems and PDF annotation tools
• Strong organizational, communication, and interpersonal skills for working in matrix environments

About the Company

Bristol Myers Squibb is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail against serious diseases. We foster a culture of inclusion, integrity, and innovation to transform patients' lives through science.