Scientific Report Writer – Clinical Pharmacology
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 (2.7.1/2.7.2) . 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
Skills & Experience:
- 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 at
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About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
