Director, Analytical Development and Clinical Quality Control
Disc Medicine
Medical Writer
Telix Pharmaceuticals Limited
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Lead the compilation, writing, and editing of high-quality regulatory documents and reports including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments
- Organize, analyze, and interpret scientific and statistical data
- 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 of the Telix clinical development pipeline
Requirements
- 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, regulations (CFR, FDA, EMA, and ICH guidelines)
- Understanding medical terminology and statistical methodology
- Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy
- Ability to accurately and clearly present clinical data
- Strong verbal, written, and interpersonal communication skills
- Proficiency in Microsoft Word
- Strong command of English language, grammar, style, logical progression
- Experience and proficiency with document templates, document toolbars and proper version control
- Demonstrated leadership capability, team player characteristics, excellent communication and interpersonal skills
- Strong project management skills; organized and self-motivated; strong attention to detail
