About the job
Telix Pharmaceuticals is an innovative and rapidly expanding radiopharmaceutical company with a global presence, including offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to fulfill the promise of precision medicine through targeted radiation therapy. We are dedicated to developing products that aim to enhance the quality of life for individuals affected by cancer and rare diseases. As part of our team, you will play a crucial role in the international rollout of our approved prostate cancer imaging agent and contribute to advancing our late-stage clinical products that address significant unmet needs in oncology and rare diseases.
Join Us at Telix
The Senior Medical Writer in Regulatory Affairs role presents a distinctive opportunity to facilitate Telix’s strategic objectives by leading and managing the writing process to expedite the clinical development of diagnostic and therapeutic assets in high-need medical areas.
In this capacity, you will oversee the creation of clinical study synopses, minutes for clinical development advisory boards and steering committees, and clinical sections of regulatory documents, collaborating closely with Global Clinical Leads, Global Clinical Operations, biostatisticians, and various cross-functional partners.
The Senior Medical Writer will also identify, engage, and manage contract medical writers as needed.
Key Responsibilities:
- Lead the compilation, writing, and editing of high-quality clinical study synopses, advisory board minutes, study steering committee documentation, and clinical sections of regulatory submissions.
- Interpret complex data, analyze published literature, define issues, establish facts, draw valid scientific conclusions, propose solutions, and craft text accordingly.
- Develop and update relevant SOPs, processes, templates, style guides, and manuals as required.
- Maintain an in-depth knowledge of the Telix clinical development pipeline.
- Prepare, review, and edit clinical documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), and regulatory submission documents (e.g., INDs, NDAs, BLAs, CTDs).
- Ensure all documents adhere to regulatory guidelines, company standards, and industry best practices.
- Manage multiple medical writing projects simultaneously, ensuring timely delivery of high-quality documents.
- Coordinate with cross-functional teams to gather necessary data and insights.