Senior Medical Writer/Principal Medical Writer
9 hours ago
Palma
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 global 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
