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 customerAbility 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 justificationsMay strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programsMay 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).Deliver regulatory training / presentations as required, internally or externallyMay mentor junior colleagues and engage in department knowledge sharingMay perform additional tasks as deemed appropriate by Line ManagerREQUIRED KNOWLEDGE, SKILLS AND ABILITIES Good understanding of the regulations, directives and guidance supporting clinical Research and DevelopmentDemonstrates comprehensive regulatory / technical expertiseGood negotiating skills and the ability to identify and resolve issues, using flexible adaptable approachStrong ownership and oversight skillsDemonstrated skills in chairing meetings and working on initiativesAbility to work on several projects, retaining quality and timelines and can prioritize workloadAbility to propose revisions to SOPs or suggest process improvements for considerationStrong mentoring skills, helping junior colleagues and setting a positive exampleInnovative and solutions-drivenStrong skills in establishing and maintaining effective working relationships with co-workers, managers and clientsStrong software and computer skills, including MS Office applicationsMINIMUM REQUIRED EDUCATION AND EXPERIENCE Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years' experience* (*or combination of education, training and experience)
PHYSICAL REQUIREMENTS Extensive use of telephone and face-to-face communication requiring accurate perception of speechExtensive use of keyboard requiring repetitive motion of fingersRegular sitting for extended periods of timeTravel might be requiredIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
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