Senior Medical Writer/Principal Medical Writer

Overview

In this role, you will lead the end-to-end creation of high-quality clinical study documents, ensuring timely delivery and adherence to regulatory standards. You will collaborate with sponsors, vendors, and internal teams to plan, write, edit, and QC key documents such as protocols, IBs, CSR-related content, and DSURs. You will apply Precision MW style guides and regulatory guidelines (ICH, FDA, GCP) and eCTD requirements to craft compliant documents with impeccable attention to detail. This position offers the opportunity to shape medical writing processes and contribute to development programs across phases. You will operate in a fast-paced environment, delivering clear messages from study

Responsibilities

• Plan, write, edit, format, and QC clinical documents (protocols, IBs, ICF templates, DSURs, CSRs, CSR narratives)
• Manage document lifecycle from template to final approved version in collaboration with sponsors, vendors, and internal teams
• Independently derive key messages from clinical study data and translate into complex content
• Author content with process understanding and ensure regulatory compliance
• Contribute to medical writing processes, SOPs, templates, and work instructions
• Conduct literature-based research to support writing activities
• Other duties as assigned

Key requirements

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
• 5+ years as a Senior Medical Writer or 7+ years as a Principal Medical Writer (sponsor/CRO)
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, PowerPoint
• Solid understanding of ICH, FDA, GCP, regulatory and clinical trial transparency requirements (EudraCT, CT.gov) and eCTD
• Impeccable attention to detail and timely delivery
• Ability to work in a fast-paced environment with multiple high-priority projects and minimal instructions

• clear written and verbal communication
• problem-solving
• self-motivated with minimal instruction
• ICH, FDA, GCP regulatory knowledge
• eCTD requirements
• literature-based research

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