Senior Medical Writer

Telix Pharmaceuticals (AMER)

2d•Hybrid

About The Position

The Senior Medical Writer in Regulatory Affairs position offers a unique opportunity to contribute to the achievement of Telix’s strategic goals by leading and driving the writing process to accelerate the clinical development of diagnostic and therapeutic assets in areas of high unmet medical need. This role will lead 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. The Senior Medical Writer will identify, engage, and manage the work of contract medical writers as required.

Requirements

Master’s degree in a scientific or related field required; PhD preferred.
8+ years’ experience in regulatory writing, including experience in Clinical Development writing required
Experience overseeing and mentoring contractors and junior team members strongly preferred
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

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.
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.