🩺 Position Title: Medical Writer
Location: USA – Remote
Company: Telix Pharmaceuticals
Updated On: Thursday, 9 October 2025
🏢 About Telix Pharmaceuticals
Telix Pharmaceuticals is a global, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States.
Our mission is to deliver on the promise of precision medicine through targeted radiation, improving the quality of life for people living with cancer and rare diseases.
You will contribute to the international roll-out of our approved prostate cancer imaging agent and help advance our late-stage oncology and rare disease portfolio.
🎯 Role Overview
The Medical Writer plays a critical role in supporting Telix’s clinical and regulatory goals by planning, authoring, and coordinating scientific and regulatory documents across all phases of clinical development.
This position involves interpreting scientific and statistical data, ensuring clarity, accuracy, and compliance with global regulatory standards.
⚙️ Key Responsibilities
Regulatory and Clinical Document Development
Lead the writing, compilation, and editing of high-quality clinical and regulatory documents including:
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
Safety Narratives & Safety Reports
Integrated Summaries of Safety (ISS) and Efficacy (ISE)
eCTD summary documents for IND, NDA, BLA, and MAA applications
Scientific Analysis and Interpretation
Interpret complex scientific and statistical data.
Conduct literature reviews, analyze findings, and synthesize conclusions logically and clearly.
Define problems, draw valid scientific conclusions, and compose well-structured text accordingly.
Collaboration and Cross-functional Support
Partner with clinical scientists, physicians, statisticians, and project teams to ensure timely and accurate document delivery.
Support responses to Health Authority (FDA, EMA, etc.) queries and requests.
Process Development and Compliance
Contribute to the development and maintenance of SOPs, templates, style guides, and documentation manuals.
Maintain updated knowledge of Telix’s clinical pipeline and global regulatory requirements.
🎓 Education & Experience
|
Requirement |
Details |
|---|---|
|
Qualification |
Bachelor’s degree in Science or related field (Advanced degree preferred) |
|
Experience |
Minimum 5+ years of experience in regulatory medical writing |
|
Regulatory Knowledge |
Strong understanding of drug development, clinical study design, CFR, FDA, EMA, and ICH guidelines |
|
Document Expertise |
Experience with protocols, IBs, CSRs, eCTD clinical summaries, ISS/ISE |
|
Technical Proficiency |
Skilled in Microsoft Word, version control tools, and document templates |
|
Communication Skills |
Excellent written and verbal English, strong grasp of grammar, structure, and logical flow |
|
Leadership & Project Management |
Demonstrated leadership, strong organization, attention to detail, and ability to manage multiple projects |
💡 Key Capabilities
🌈 Inclusive mindset: Foster diversity and respect for all team members
💭 Creativity & Innovation: Think outside the box and propose novel solutions
🏆 Commitment to Excellence: Maintain the highest standards in writing and documentation
🎯 Results-oriented: Deliver accurate and impactful documents on time
⚖️ Ethical Behavior: Act with integrity and maintain confidentiality
🔄 Adaptability: Work effectively in fast-changing environments
🗣️ Strong Communication: Collaborate efficiently with colleagues across departments
🤝 Collaboration: Promote teamwork and shared success
💪 Resilience: Stay composed under pressure and meet tight deadlines
📚 Continuous Learning: Stay current with evolving regulatory and scientific standards
💼 Why Join Telix
Join a global, mission-driven team pioneering precision medicine.
Flexible hybrid and remote work environment with international collaboration.
Competitive salary, annual performance bonuses, equity-based incentives, and wellness benefits.
Opportunities for learning, growth, and professional development.
Be part of a culture that values excellence, integrity, and compassion.
⚖️ Equal Opportunity Statement
Telix Pharmaceuticals is an equal opportunity employer.
We evaluate all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
🔗 Learn More: [Telix Pharmaceuticals LinkedIn Page]
📄 Privacy Policy: Available on official website
📩 Apply Now: [Click Here to Apply]
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