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Scientific Report Writer – Clinical Pharmacology
il y a 2 semaines
We are seeking a Scientific Report Writer to support full Clinical Study Report (CSR) writing for Phase 1 , protocol development, and preparation of regulatory modules (2.7.1/ This role requires strong scientific writing skills and attention to detail to ensure high-quality, inspection-ready deliverables.
- Key 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
- Review documents, compile comments, and ensure timely resolution in collaboration with stakeholders
- Perform QC of reports and manage review cycles
- Support development of reporting templates, analysis plans, and data transfer plans
- Draft and review protocols, statistical analysis plans, TLFs/TLF shells, and CSRs
- Conduct Non-Compartmental Analysis (NCA) using Phoenix WinNonlin 8.3 (preferred but not mandatory)
- Draft and review programming specifications for studies
- Strong experience in scientific report writing and document QC procedures
- Proficient in Word templates and document formatting
- Excellent communication skills (oral and written) in English
- Familiarity with PK/PD analysis tools and processes, including Phoenix WinNonlin (preferred but not mandatory)
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
