Medical Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Play a vital role in achieving Telix’s strategic objectives by spearheading the writing process.

• Accountable for the planning and preparation of various clinical and regulatory documents essential for all stages of clinical drug development.

• Offer medical writing assistance by structuring, analyzing, and interpreting scientific and statistical information.

• Oversee the compilation, writing, and editing of high-quality regulatory documents and reports, primarily of a clinical nature.

• Analyze data, research and evaluate published literature, identify issues, establish facts, draw valid scientific conclusions, propose solutions or corrective measures, and draft text accordingly.

• Collaborate with colleagues, physicians, clinical scientists, and statisticians in a professional and structured manner to ensure timely project completion.

• Partner with project teams to address inquiries and requests from health authorities.

• Create and update relevant SOPs, processes, templates, style guides, and manuals as necessary.

• Maintain expertise to ensure the effective execution of responsibilities as a medical writing specialist.

⛳️ Requirements

• Bachelor’s degree with a focus in science or a related field is required; an advanced degree is preferred.

• Minimum of 5 years of experience in regulatory medical writing is required.

• In-depth understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles.

• Proficient in writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy.

• Ability to present clinical data accurately and clearly; strong verbal, written, and interpersonal communication skills; proficiency in Microsoft Word is required.

• Excellent command of the English language, grammar, style, and logical progression.

• Capable of writing in a clear, concise, and persuasive manner, as well as reviewing and editing at all levels, from copy editing to enhancing messages to major rewriting.

• Experience and proficiency with document templates, document toolbars, and proper version control.

• Proven leadership capabilities. Possess good team player attributes. Excellent communication and interpersonal skills. Strong project management abilities. Organized, self-motivated, and attentive to detail.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development.