Medical Writer

About The Job

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

We are seeking an engaging and experienced Medical Writer or Senior Medical Writer. This position offers a unique opportunity to contribute to the achievement of Telixs strategic goals by leading and driving the writing process to accelerate clinical development of diagnostic and therapeutic assets in areas of high unmet medical need.

This role will lead the preparation of clinical study synopses, minutes for clinical development advisory boards and steering committees, and clinical sections of regulatory documents in close collaboration with the Global Clinical Leads, Global Clinical Operations, biostatisticians, and other cross-functional colleagues.

The Medical Writer will identify, engage, and project manage the work of contract medical writers as required.

What You'll Do

• Lead the compilation, writing, and editing of high-quality clinical study synopses, minutes of advisory boards and study steering committees, and clinical sections of regulatory documents
• 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.
  
  
  

About You

• Bachelor of Science a science or related field required; masters or PhD preferred.
• 8+ years of experience in pharmaceutical industry with 5+ years of experience in regulatory writing required for Medical Writer; 8+ years experience in regulatory writing required for Senior Medical Writer
• Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding medical terminology and statistical methodology is a must.
• Experience writing clinical study synopses, minutes, and clinical sections of regulatory documents.
• Experience and proficiency with document templates, document toolbars and proper version control.
• Strong project management skills. Organized and self-motivated. Strong attention to detail.
  
  
  

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