Medical Writer I

Medical Writer I responsible for authoring and delivering clinical documents for regulatory submissions. Key duties include drafting, reviewing, and finalizing clinical study reports, informed consent forms, and safety update reports; performing literature searches; ensuring compliance with SOPs, templates, and regulatory guidelines (FDA/EMA/ICH-GCP) while maintaining document quality and consistency; providing medical editing and review of drafts; acting as primary client contact for project timelines, coordinating interdepartmental reviews, and leading authoring team meetings; training and mentoring junior staff; managing and organizing project documentation and file management; ensuring documents meet publishing readiness and regulatory standards; demonstrating strong written and verbal communication skills and proficiency with MS Office and collaborative tools like SharePoint. Skills include attention to detail, organizational ability, adaptability, teamwork in a matrix environment, and knowledge of regulatory guidelines and drug development processes.