Senior Medical Writer

Telix Pharmaceuticals - Fishers, IN

Full-time - Senior

Fishers, IN

Professional, Scientific, and Technical Services

About the position

We are seeking an experienced Senior Medical Writer in Regulatory Affairs. This 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.

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.

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.

Nice-to-haves

• Experience in a pharmaceutical or biotechnology company
• Familiarity with electronic document management systems
• Knowledge of clinical trial management systems (CTMS)
• Experience with regulatory submissions to health authorities.