Medical Writer

🕒 May 4

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• Contribute to the achievement of Telix’s strategic goals by leading and driving the writing process • Responsible for planning and preparing a variety of clinical and regulatory documents necessary for all phases of clinical drug development • Provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data • Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) • Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly • Work with colleagues, physicians, clinical scientists, and statisticians in a professional and organized manner to complete projects in a timely manner • Collaborate with project teams to respond to health authority questions and requests • Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed • Maintain knowledge to enable ongoing execution of function as medical writing expert

🎯 Requirements

• Bachelor with a focus in science or related field required; Advance degree preferred • 5+ years of experience in regulatory medical writing required • Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles • Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy • The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word are required • Strong command of English language, grammar, style, logical progression • Ability to write in a clear, concise, and persuasive manner, as well as to review and edit on all levels, from copy editing to message strengthening to major rewriting • Experience and proficiency with document templates, document toolbars and proper version control • Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail.

🏖️ Benefits

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