Principal Medical Writer
ICON plc
Job Level
Lead
About the role
- Developing and authoring clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.
- Ensuring all documents comply with regulatory guidelines and company standards for quality and accuracy.
- Collaborating with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to gather and interpret clinical data.
- Mentoring and guiding junior medical writers, fostering a culture of excellence and continuous improvement.
- Reviewing and editing documents prepared by other writers to ensure consistency and adherence to regulatory requirements.
- Staying current with industry trends and regulatory changes to integrate best practices into medical writing processes.
- Contributing to the development of templates, style guides, and standard operating procedures to enhance the efficiency and quality of medical writing activities.
Requirements
- Extensive experience in medical writing, with a proven track record of developing clinical and regulatory documents in the pharmaceutical or biotech industry.
- Strong proficiency in scientific writing and editing, with excellent attention to detail.
- Excellent analytical and problem-solving skills, with the ability to interpret complex clinical data and present it clearly.
- Demonstrated leadership skills, with experience in managing and mentoring teams effectively.
- Exceptional communication skills, with the ability to convey technical concepts to diverse audiences.
- Detail-oriented, with strong organizational skills to manage multiple projects and deadlines in a dynamic environment.
