Job Overview
The Senior Medical Writer plays a critical role in regulatory and clinical projects, combining scientific expertise with writing skills to produce high-quality documents that drive strategic decision-making.
Main Responsibilities
* Leverage scientific knowledge to author, review, finalize, and approve regulated documents for development and marketed products, including electronic Common Technical Document (eCTD) modules, health authority briefing packages, and clinical trial operational documents.
* Contribute to the development and implementation of robust systems for document management.
* Provide medical writing expertise to regulatory and clinical development teams.
Requirements
* Bachelor's degree in a physical or biological science, with 5 years of relevant experience.
* Master's degree with 4 years of experience.
* Doctoral-level degree (PhD, MD, DVM, DO, PharmD) with 3 years of relevant career experience.
Key Skills
* Fluency in English, preferably at C2 level or native speaker.
* Demonstrated ability to understand and apply scientific concepts.
* Good understanding of statistical principles.
* Care
* Courage
* Innovation
* Simplicity