Telix Pharmaceuticals is a dynamic, 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. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix
We are seeking an experienced leader for the Medical and Technical (CMC) Writing team within Global Regulatory Affairs. This position offers a unique opportunity to contribute to the achievement of Telix’s strategic goals by leading and driving the regulatory writing process across both clinical and CMC/quality to accelerate the development of diagnostic and therapeutic assets in areas of high unmet medical need.
This role will lead a team of medical writers in the preparation of clinical study synopses, minutes for clinical development advisory boards and steering committees, and clinical sections of regulatory documents in close collaboration with the Global Clinical Leads, Global Clinical Operations, biostatisticians, and other cross-functional colleagues.
This role will also lead a team of technical/CMC regulatory writers in the preparation of the quality (module 3) CTD sections of regulatory dossiers and briefing books for agency meetings from internal CMC source documentation.
Key Accountabilities
• Lead the compilation, writing, and editing of high-quality clinical study synopses, minutes of advisory boards and study steering committees, and clinical sections of regulatory documents
• Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions and compose text accordingly.
• Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed.
• Maintain working knowledge of the Telix clinical development pipeline.
• Prepare, review, and edit clinical documents including, but not limited to, 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 comply with regulatory guidelines, company standards, and industry best practices.
• Lead and manage multiple medical 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.
• Work closely with CMC, Operations and QA teams to ensure alignment and accuracy of module 3 documents to manufacturing source documents.
• Provide medical writing expertise and support to project teams, contributing to strategic planning and decision-making.
• Mentor and train junior medical and technical 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.
Education And Experience
• Education and Experience:
• Master’s degree in a scientific or related field required; PhD preferred.
• 12+ years’ experience in regulatory writing, including experience in Clinical Development writing required
• Experience in writing regulatory CMC (module 3) preferred
• 5+ years’ experience in overseeing and mentoring contractors and junior team members required
• Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding medical terminology and statistical methodology is a must.
• Experience writing clinical study synopses, minutes, and clinical sections of regulatory documents required
• Experience and proficiency with document templates, document toolbars and proper version control.
• Strong project management skills. Organized and self-motivated. Strong attention to detail.
• Key Capabilities:
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
VIEW OUR PRIVACY POLICY HERE
Location: , , US
Offer Expires: 2024-10-30 17:28:55
Job Posting Language: en
Benefits:
- Paid Time Off
Qualifications:
- 12+ years’ experience in regulatory writing, including experience in Clinical Development writing required
- 5+ years’ experience in overseeing and mentoring contractors and junior team members required
- Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles
- Understanding medical terminology and statistical methodology is a must
- Experience writing clinical study synopses, minutes, and clinical sections of regulatory documents required
- Experience and proficiency with document templates, document toolbars and proper version control
- Strong project management skills
- Organized and self-motivated
- Strong attention to detail
- Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
- Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
- Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
- Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
- Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
Responsibilities:
- This position offers a unique opportunity to contribute to the achievement of Telix’s strategic goals by leading and driving the regulatory writing process across both clinical and CMC/quality to accelerate the development of diagnostic and therapeutic assets in areas of high unmet medical need
- This role will lead a team of medical writers in the preparation of clinical study synopses, minutes for clinical development advisory boards and steering committees, and clinical sections of regulatory documents in close collaboration with the Global Clinical Leads, Global Clinical Operations, biostatisticians, and other cross-functional colleagues
- This role will also lead a team of technical/CMC regulatory writers in the preparation of the quality (module 3) CTD sections of regulatory dossiers and briefing books for agency meetings from internal CMC source documentation
- Lead the compilation, writing, and editing of high-quality clinical study synopses, minutes of advisory boards and study steering committees, and clinical sections of regulatory documents
- Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions and compose text accordingly
- Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed
- Maintain working knowledge of the Telix clinical development pipeline
- Prepare, review, and edit clinical documents including, but not limited to, 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 comply with regulatory guidelines, company standards, and industry best practices
- Lead and manage multiple medical 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
- Work closely with CMC, Operations and QA teams to ensure alignment and accuracy of module 3 documents to manufacturing source documents
- Provide medical writing expertise and support to project teams, contributing to strategic planning and decision-making
- Mentor and train junior medical and technical 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
Benefits:
- We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development
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