Principal Medical Writer
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Remote • New York • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
- 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.
- Mentoring and training junior medical writers, fostering a culture of excellence and professional growth.
- Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs.
Requirements
- Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred.
- 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
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingregulatory submissionsclinical documentationwritingediting
Soft skills
communicationinterpersonal skillsmentoringcollaborationattention to detail
Certifications
advanced degree in life sciencesadvanced degree in medicinerelevant certifications