Medical Writer

Role Summary

Medical Writer responsible for planning and preparing regulatory and clinical documents across all phases of clinical drug development, guiding the writing process, and providing 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 including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summaries 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 the medical writing function and maintain knowledge of the Telix clinical development pipeline.

Qualifications

• Required: Bachelor of Science in a science or related field; Advanced degree preferred.
• Required: 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; proficiency in medical terminology and statistical methodology; strong writing and editing skills.
• Required: Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated safety and efficacy summaries.
• Required: Ability to present clinical data clearly; strong verbal, written, and interpersonal communication skills; proficiency in Microsoft Word.
• Required: Excellent English language, grammar, style, logical progression; ability to write clearly and concisely and to edit at all levels.
• Required: Experience with document templates, toolbars, and version control; demonstrated leadership; strong project management; detail-oriented.

Skills

• Medical writing leadership and project management
• Data interpretation and literature analysis
• Regulatory documentation (eCTD, CSRs, IBs, safety narratives, ISS/ISE)
• Clinical study design and regulatory guidelines (CFR, FDA, EMA, ICH)
• Strong written and verbal communication; collaboration with cross-functional teams
• Template and document control proficiency

Education

• Bachelor of Science in a science or related field; advanced degree preferred

Additional Requirements

• None beyond listed qualifications