Medical Writer
Telix Pharmaceuticals Limited
August 29, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Medical Writer responsible for leading and driving the writing process and planning/preparing clinical and regulatory documents for all phases of clinical drug development. Provides medical writing support by organizing, analyzing, and interpreting scientific and statistical data.
Key Accountabilities
- Lead compilation, writing, and editing of high-quality regulatory documents/reports (primarily clinically oriented), including CSRs, Investigator Brochures, 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 scientific conclusions; propose solutions/corrective actions; compose text.
- Work with colleagues, physicians, clinical scientists, and statisticians to complete projects on time.
- Collaborate with project teams to respond to health authority questions/requests.
- Develop and update SOPs, processes, templates, style guides, and manuals as needed.
- Maintain knowledge to execute medical writing expertise and maintain working knowledge of the clinical development pipeline.
Education and Experience / Qualifications
- Bachelor’s in 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; medical terminology and statistical methodology required.
- Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated safety/efficacy summaries.
- Ability to present clinical data clearly; strong verbal/written/interpersonal skills; proficiency in Microsoft Word.
- Strong English/grammar/style; ability to write and edit at all levels.
- Experience with document templates/tools and proper version control.
- Demonstrated leadership, strong project management, organized/self-motivated, attention to detail.
Application instructions: VIEW OUR PRIVACY POLICY HERE
Key Accountabilities
- Lead compilation, writing, and editing of high-quality regulatory documents/reports (primarily clinically oriented), including CSRs, Investigator Brochures, 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 scientific conclusions; propose solutions/corrective actions; compose text.
- Work with colleagues, physicians, clinical scientists, and statisticians to complete projects on time.
- Collaborate with project teams to respond to health authority questions/requests.
- Develop and update SOPs, processes, templates, style guides, and manuals as needed.
- Maintain knowledge to execute medical writing expertise and maintain working knowledge of the clinical development pipeline.
Education and Experience / Qualifications
- Bachelor’s in 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; medical terminology and statistical methodology required.
- Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated safety/efficacy summaries.
- Ability to present clinical data clearly; strong verbal/written/interpersonal skills; proficiency in Microsoft Word.
- Strong English/grammar/style; ability to write and edit at all levels.
- Experience with document templates/tools and proper version control.
- Demonstrated leadership, strong project management, organized/self-motivated, attention to detail.
Application instructions: VIEW OUR PRIVACY POLICY HERE