See Yourself at Telix

The Medical Writer/Senior Medical Writer will contribute to the achievement of Telix’s strategic goals by leading and driving the writing process. This role will be responsible for planning and preparing a variety of clinical and regulatory documents necessary for all phases of clinical drug development.

This role will provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data. Such documents include all types of regulatory documents, including eCTD summary documents (for INDs/NDAs/BLAs), clinical study reports, clinical study protocol synopses and protocols, Investigator Brochures, patient safety narratives, and briefing books, among others.

Key Accountabilities

• 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.

Education and Experience

• Bachelor of Science a science or related field required; Advance degree 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 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 are required.
• Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as to review and edit on all levels, from copy editing to message strengthening to major rewriting.
• 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.