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
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 https://jobs.iqvia.com
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.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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