Principal Medical Writer
ICON plc
full-time
Posted on:
Location Type: Remote
Location: United Kingdom
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Job Level
About the role
- Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
- Perform medical writing tasks, especially medical writing tasks of high complexity and critical to project(s) and strategic area
- Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development.
- Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards.
Requirements
- Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred.
- Minimum 5 years of experience as a regulatory medical writer
- Significant experience in medical writing, particularly in regulatory submissions and clinical documentation.
- Strong understanding of regulatory requirements and industry standards for clinical writing.
- Exceptional writing and editing skills, with a keen eye for detail and clarity.
- Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.
- A commitment to maintaining high standards of quality and compliance in all medical writing activities.
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingregulatory submissionsclinical documentationdocument developmentwriting and editing
Soft Skills
communicationinterpersonal skillscollaborationattention to detailcommitment to quality
Certifications
advanced degree in life sciencesadvanced degree in medicinerelevant certifications