Overview

Medical Writer role at Telix Pharmaceuticals Limited. Telix is a radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. The role supports the international roll-out of the approved prostate cancer imaging agent and advances the portfolio of late clinical-stage products addressing unmet needs in oncology and rare diseases.

The Medical Writer will lead and drive the writing process, planning and preparing clinical and regulatory documents necessary for all phases of clinical drug development. The role provides medical writing support by organizing, analyzing, and interpreting scientific and statistical data.

Responsibilities

• 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 to complete projects in a timely manner.
• Collaborate with project teams to respond to health authority questions and requests.
• Develop and update SOPs, processes, templates, style guides, and manuals as needed.
• Maintain knowledge to enable ongoing execution of function as medical writing expert and maintain working knowledge of the Telix clinical development pipeline.

Education and Experience

• Bachelor of Science in a science or related field required; advanced degree preferred
• 5+ years of experience in regulatory medical writing required
• Strong understanding of drug development, clinical study design, CFR, FDA, EMA, ICH guidelines, and scientific principles; medical terminology and statistical methodology
• Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated safety and efficacy summaries
• Ability to present clinical data clearly; strong verbal, written, and interpersonal communication; proficiency in Microsoft Word
• Strong command of English language, grammar, style, logical progression; ability to write clearly, concisely, persuasively; ability to review and edit at all levels
• Experience with document templates, toolbars, and version control
• Demonstrated leadership, team collaboration, project management, organization, motivation, and attention to detail

Key Capabilities

• Inclusive mindset
• Creativity and innovation
• Commitment to excellence
• Results-oriented
• Ethical behavior
• Adaptability
• Strong communication
• Collaboration
• Resilience
• Continuous learning

About Telix and Benefits

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of a global, interdisciplinary team delivering precision medicine. We offer hybrid/remote work options, competitive salaries, annual performance bonuses, equity-based incentives, generous vacation, paid wellness days, and development support.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR RECRUITMENT PRIVACY POLICY HERE

Job Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Marketing, Public Relations, and Writing/Editing
• Industries: Pharmaceutical Manufacturing