Regulatory Manager, Clinical Trials Regulatory Management- Home-Based, Emea

Há 6 dias


Lisboa, Portugal Iqvia Tempo inteiro

.Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA Lisboa Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEALisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers. Ability to write scientific documents e. g. Investigational Medicinal Product Dossier, clinical trial justifications May strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programs May provide support on key regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs) Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met. Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA)



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