RN specializing in clinical documentation integrity for pediatric patients at Connecticut Children's. Collaborating with healthcare providers to enhance documentation standards and accuracy.
About the role
- Principal Medical Writer at IQVIA producing inspection-ready Clinical Study Reports for Phase 1 studies. Collaborating with teams to ensure compliance with regulatory and internal guidelines while maintaining document quality.
Responsibilities
- Ensure all deliverables are inspection-ready and compliant with regulatory and internal guidelines
- Maintain central planning for document writing and QC deliverables
- Provide recommendations for process improvements to enhance collaboration between CPP and document service teams
- Drive document shell creation, QC processes, and timeline management
Requirements
- Strong experience in writing full CSR for Phase 1 clinical pharmacology studies.
- Strong experience on protocol writing and Module 2.7.1/2.7.2 (SBAAM/SCP) writing
- Proficient with word templates and document formatting
- Experience authoring Health Authority responses is required.
- Excellent communication skills (oral and written) in English.
Benefits
- Health insurance
- Retirement plans
- Professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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