Medical Writer
Telix Pharmaceuticals Limited
August 07, 2026
Remote friendly (United States)
United States
Medical Affairs
Medical Writer
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/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 execute the function as a medical writing expert and maintain working knowledge of the clinical development pipeline.
Education and Experience / Qualifications:
- Bachelor’s degree 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, ICH), and scientific principles; 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.
- Ability to accurately present clinical data; strong communication skills; proficiency in Microsoft Word.
- Strong English grammar/style and ability to write, review, edit, and rewrite clearly and persuasively.
- Experience with document templates, document toolbars, and proper version control.
- Demonstrated leadership, project management, organization, self-motivation, and attention to detail.
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/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 execute the function as a medical writing expert and maintain working knowledge of the clinical development pipeline.
Education and Experience / Qualifications:
- Bachelor’s degree 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, ICH), and scientific principles; 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.
- Ability to accurately present clinical data; strong communication skills; proficiency in Microsoft Word.
- Strong English grammar/style and ability to write, review, edit, and rewrite clearly and persuasively.
- Experience with document templates, document toolbars, and proper version control.
- Demonstrated leadership, project management, organization, self-motivation, and attention to detail.