Principal Medical Writer – Clinical Pharmacology (mwd)
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a Principal Medical 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 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
Skills & Experience:
- 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.
- Proficient in Word templates and document formatting
- Excellent communication skills (oral and written) in English
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
Staff IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
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
