Senior Medical Writer/Principal Medical Writer

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Overseeing the creation of high-quality clinical study documents delivered on schedule.

• Planning, writing, editing/formatting clinical documents, and conducting quality control reviews.

• Generating documents in accordance with the Precision MW Style Guide, Precision SOPs, and relevant regulatory standards (such as ICH, FDA, GCP) as well as eCTD requirements.

• Facilitating seamless and efficient document management from inception to completion (from template to final approved version), collaborating with Sponsors, external vendors, and/or internal Precision project teams/departments.

• Capable of independently articulating key messages derived from clinical study data.

• Skilled in producing complex content using expertise and understanding of the relevant processes.

• Assisting in the development and upkeep of medical writing processes, SOPs, templates, and work instructions for essential documents.

• Conducting literature-based research to support writing endeavors.

⛳️ Requirements

• A BS degree or equivalent in a scientific or medical field with relevant writing experience.

• Minimum of 5 years of experience as a Senior Medical Writer in a sponsor and/or CRO environment, or over 7 years as a Principal Medical Writer.

• Proficient in Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.

• Strong understanding of relevant regulations (e.g., ICH, FDA, GCP), clinical trial transparency requirements (such as EudraCT, CT.gov), and eCTD requirements across all development phases.

• Exceptional attention to detail and the ability to complete writing tasks punctually.

• Competence to work efficiently in a dynamic environment with multiple high-priority projects, requiring minimal guidance on routine tasks and limited instruction on new assignments.

🏝️ Benefits

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• Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.

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