Director, Delivery Lead - Engineering Enablement
Travelers
Principal Medical Writer
ICON plc
full-time
Posted on:
Origin: • 🇺🇸 United States • North Carolina, Pennsylvania
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.
