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.

• Organizing, composing, revising, formatting, and conducting quality control reviews of clinical documents such as clinical study protocols, Investigator Brochures, Informed Consent Form templates, Development Safety Update Reports, Clinical Study Reports, and patient narratives for Clinical Study Reports.

• Facilitating seamless and efficient document management from inception to completion in partnership with sponsors, external vendors, and/or internal Precision project teams and departments.

• Capability to independently derive key messages from clinical study data.

• Proficiency in drafting intricate content utilizing knowledge, skills, and process understanding.

• Competence in communicating clearly and succinctly, both in writing and verbally, with internal and client teams.

• Aiding in the formulation and upkeep of medical writing processes, Standard Operating Procedures, templates, and work instructions for essential documents.

• Outstanding problem-solving abilities.

• Conducting literature-based research to support writing tasks.

⛳️ Requirements

• Bachelor’s degree or equivalent in a scientific or medical field with relevant writing experience.

• Over 5 years of experience as a Senior Medical Writer in a sponsor and/or Contract Research Organization setting, or more than 7 years of experience 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 mandates (i.e., EudraCT, CT.gov), and eCTD requirements for all development phases.

• Exceptional attention to detail and ability to complete writing projects promptly.

• Ability to thrive in a dynamic environment handling multiple high-priority projects with little guidance on routine tasks and minimal direction on new assignments.

🏝️ Benefits

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