Overview
In this senior role, you drive the creation of high-quality clinical study documents, from planning through QC, aligned with regulatory standards. You will collaborate with sponsors, vendors, and internal teams to ensure timely, compliant manuscripts and templates. Your expertise shapes content strategy, standards, and processes for general regulatory submissions. This is a hands-on writing leadership role with a clear focus on precision, deadlines, and impact on development programs.
Responsabilidades Plan, write, edit, format, and QC clinical documents (protocols, IBs, ICF templates, DSURs, CSRs, CSR narratives)
Manage end-to-end document lifecycle from template to final approved version in collaboration with sponsors, vendors, and internal teams
Independently extract and formulate key messages from clinical study data
Author complex content leveraging regulatory guidelines and study processes




Contribute to medical writing processes, SOPs, templates, and work instructions
Conduct literature-based research to support writing activities
Perform other duties as assigned
Requisitos principales BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
5+ years as a Senior Medical Writer in sponsor/CRO setting or 7+ years as Principal Medical Writer
Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, PowerPoint
Strong understanding of ICH, FDA, GCP, clinical trial transparency (EudraCT, CT.gov), and eCTD requirements
excellent written and verbal communication
impeccable attention to detail
strong problem-solving abilities
Microsoft Word
Microsoft PowerPoint
Microsoft Excel

📌 Senior Medical Writer/Principal Medical Writer (León)
🏢 Precision Medicine Group
📍 León