Technical Writer

Summary

Join Telix Pharmaceuticals, a fast-growing radiopharmaceutical company, as a Technical (CMC) Writer in Regulatory Affairs. This role involves leading the preparation of quality/CMC sections for regulatory dossiers and associated documents. You will manage contract technical writers, ensure compliance with regulatory guidelines, and collaborate with cross-functional teams. The ideal candidate possesses a scientific background, extensive experience in technical writing within regulatory CMC, and strong project management skills. Telix offers a competitive compensation package including bonuses, equity incentives, generous vacation time, wellness days, and support for professional development.

Requirements

• Bachelor’s degree in a scientific or related field required
• 5+ years’ overall experience in technical/CMC writing, 2+ years within Regulatory CMC required
• Strong understanding of drug development, drug substance and drug product manufacturing, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles
• Experience and proficiency with document templates, document toolbars and proper version control
• Strong project management skills
• Organized and self-motivated
• Strong attention to detail

Responsibilities

• Lead the compilation, writing, and editing of high-quality module 3 documents
• Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed
• Maintain working knowledge of the Telix development pipeline
• Prepare, review, and edit regulatory submission documents (e.g., INDs, NDAs, BLAs, CTDs)
• Ensure all documents comply with regulatory guidelines, company standards, and industry best practices
• Lead and manage multiple regulatory technical writing projects simultaneously, ensuring timely delivery of high-quality documents
• Coordinate with cross-functional teams to gather necessary information and resolve any issues that arise during the document development process
• Conduct thorough reviews of documents for accuracy, consistency, and clarity as needed
• Work closely with clinical development teams, including clinical operations, regulatory affairs, biostatistics, physicians, and medical affairs, to ensure alignment and accuracy of clinical documents
• Provide medical writing expertise and support to project teams, contributing to strategic planning and decision-making
• Mentor and train junior medical writers, providing guidance and support to enhance their skills and career development, along with oversight to external contractors
• Stay current with industry trends, guidelines, and best practices, and share knowledge with the team
• Support regulatory submissions by preparing high-quality documentation and addressing health authority comments and queries
• Ensure compliance with regulatory requirements and timelines for all submission-related activities

Preferred Qualifications

• MS or PhD preferred
• Experience overseeing and mentoring contractors and junior team members strongly preferred

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development