Medical Writer

Role: Medical Writer supporting Telix Pharmaceuticals' clinical regulatory documentation for radiopharmaceuticals, primarily focused on oncology and rare diseases. Responsibilities: lead the compilation, writing, and editing of high-quality regulatory documents, including IND/CTA submissions, clinical study reports, Investigator Brochures, safety narratives, and eCTD summaries; interpret and analyze scientific and statistical data; collaborate with multidisciplinary teams to respond to health authority queries; develop SOPs and templates; maintain expertise in clinical development pipeline. Requirements: Bachelor's in science or related field (advanced degree preferred); 5+ years of regulatory medical writing experience; strong understanding of drug development, clinical trial design, FDA/EMA/ICH regulations; proficient in scientific terminology, statistical concepts, and regulatory document formats; excellent written/verbal communication, editing, and project management skills; proficiency in MS Word. Preferred: experience with biologics or radiopharmaceuticals in late clinical stages (Phase 3 or post-market); familiarity with GxP standards and international submissions. HighValue: focus on oncology, radiopharmaceuticals, IND/BLA applications, clinical study reports and summaries, cross-functional collaboration with clinical/scientific teams. WorkSetup: hybrid/remote globally.