Medical Writer

Telix Pharmaceuticals - Fishers, IN

- Mid Level

Fishers, IN

Professional, Scientific, and Technical Services

About the position

The Medical Writer will contribute to the achievement of Telix' strategic goals by leading and driving the writing process. This role will be responsible for planning and preparing a variety of clinical and regulatory documents necessary for all phases of clinical drug development. This role will provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data. Such documents include all types of regulatory documents, including eCTD summary documents (for INDs/NDAs/BLAs), clinical study reports, clinical study protocol synopses and protocols, Investigator Brochures, patient safety narratives, and briefing books, among others.

Responsibilities

• Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments.
• 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. Maintain working knowledge of the Telix clinical development pipeline.

Requirements

• Bachelor of Science in a science or related field required; Advanced 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
• Ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; proficiency in Microsoft Word
• Strong command of English language, grammar, style, logical progression; ability to write in a clear, concise, and persuasive manner
• 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.