Medical Writer

Role Summary

The Medical Writer will lead and drive the writing process to support Telix’s clinical development programs. This role plans and prepares a variety of clinical and regulatory documents across all phases of drug development, and provides medical writing support by organizing, analyzing, and interpreting scientific and statistical data. Documents include regulatory submissions such as eCTD modules (INDs/NDAs/BLAs), clinical study reports, study protocols and synopses, Investigator Brochures, patient safety narratives, and briefing books.

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 in a professional and organized manner to complete projects in a timely manner.
• Collaborate with project teams to respond to health 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.

Qualifications

• Required: Bachelor of Science in a science or related field
• Preferred: Advanced degree
• Required: 5+ years of regulatory medical writing experience
• Required: Strong understanding of drug development, clinical study design, CFR, FDA, EMA, and ICH guidelines, and scientific principles
• Required: Proficiency in medical terminology and statistical methodology
• Required: Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy
• Required: Ability to present clinical data clearly; strong verbal, written, and interpersonal communication skills; proficiency in Microsoft Word
• Required: Excellent command of English language, grammar, style, logical progression; ability to write clearly and concisely; ability to edit and rewrite
• Required: Experience with document templates, document toolbars and proper version control
• Required: Demonstrated leadership capability; strong teamwork; excellent communication and interpersonal skills; strong project management; organized and detail-oriented

Skills

• Inclusive mindset: Understand and appreciate diversity; contribute to an inclusive environment
• Creativity and innovation: Think outside the box and develop creative solutions
• Commitment to excellence: Strive for excellence in all work
• Results-oriented: Focus on delivering measurable results
• Ethical behavior: Act with integrity in all interactions
• Adaptability: Thrive in a dynamic environment and adjust to changing priorities
• Strong communication skills: Communicate effectively with colleagues and stakeholders
• Collaboration: Work well within a team and share knowledge
• Resilience: Recover quickly from setbacks
• Continuous learning: Commit to ongoing professional development