🩺 Position Title: Medical Writer
Location: Canada – Remote
Company: Telix Pharmaceuticals
Updated On: Thursday, 9 October 2025
🏢 About Telix Pharmaceuticals
Telix Pharmaceuticals is a global 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 to improve the quality of life for people with cancer and rare diseases.
You will support the global launch of our approved prostate cancer imaging agent and contribute to advancing our late-stage oncology and rare disease pipeline.
🎯 Role Overview
The Medical Writer will contribute to Telix’s strategic and clinical objectives by planning, developing, and managing high-quality clinical and regulatory documents across all stages of drug development.
This role involves analyzing and interpreting scientific and statistical data and ensuring regulatory documents meet global submission standards.
⚙️ Key Responsibilities
Clinical & Regulatory Document Preparation
Lead the writing, compilation, and editing of key regulatory and clinical 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, MAA submissions
Ensure clarity, scientific accuracy, and compliance with regulatory standards.
Scientific Data Analysis
Interpret and summarize scientific and statistical data effectively.
Conduct literature searches, analyze published data, and compose scientifically sound text.
Define issues, establish facts, and draw logical, evidence-based conclusions.
Cross-Functional Collaboration
Collaborate with physicians, clinical scientists, statisticians, and regulatory teams to ensure timely document delivery.
Support preparation of responses to Health Authority (e.g., FDA, EMA) queries.
Process & Knowledge Management
Develop and maintain SOPs, style guides, templates, and manuals for medical writing.
Stay updated with Telix’s clinical development pipeline and relevant regulatory guidelines.
🎓 Education & Experience
|
Criteria |
Requirements |
|---|---|
|
Education |
Bachelor’s degree in Science or related field (Advanced degree preferred) |
|
Experience |
Minimum 5+ years in regulatory medical writing |
|
Knowledge Areas |
Drug development process, clinical study design, CFR, FDA, EMA, and ICH guidelines |
|
Technical Expertise |
Proficiency in Microsoft Word, document templates, and version control tools |
|
Writing Skills |
Strong command of English grammar, style, and scientific clarity |
|
Documents Handled |
Protocols, Investigator Brochures, CSRs, eCTD summaries, ISS/ISE |
|
Soft Skills |
Excellent communication, leadership, organization, and time management |
💡 Key Capabilities
🌈 Inclusive Mindset: Foster diversity and create a respectful workplace.
💭 Creativity & Innovation: Bring fresh ideas and solutions to writing challenges.
🏆 Commitment to Excellence: Uphold the highest scientific and editorial standards.
🎯 Results-Oriented: Focus on meeting project goals and regulatory deadlines.
⚖️ Ethical Conduct: Demonstrate integrity in all professional interactions.
🔄 Adaptability: Excel in fast-paced and evolving project environments.
🗣️ Communication: Convey complex scientific data in clear, concise language.
🤝 Collaboration: Partner effectively with global, cross-functional teams.
💪 Resilience: Manage pressure and maintain productivity under tight deadlines.
📚 Continuous Learning: Stay updated on industry trends and evolving guidelines.
💼 Why Join Telix
Join a mission-driven global team transforming cancer care through precision medicine.
Work in a hybrid or fully remote environment with international exposure.
Competitive salary, annual bonuses, equity-based incentives, and wellness programs.
Access to generous vacation, paid wellness days, and career development opportunities.
Be part of a collaborative, innovative, and supportive global community.
⚖️ 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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