Medical Writer

September 24

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Telix Pharmaceuticals Limited

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

501 - 1000 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments. • Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly. • Work with colleagues, physicians, clinical scientists, and statisticians in a professional and organized manner to complete projects in a timely manner. • Collaborate with project teams to respond to heath authority questions and requests. • Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed. • Maintain knowledge to enable ongoing execution of function as medical writing expert. Maintain working knowledge of the Telix clinical development pipeline.

🎯 Requirements

• Bachelor of Science a science or related field required; Advance degree preferred • 5+ years of experience in regulatory medical writing required • Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles • Understanding medical terminology and statistical methodology • Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy • The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word • Strong command of English language, grammar, style, logical progression • Experience and proficiency with document templates, document toolbars and proper version control • Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail.

🏖️ Benefits

• We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.