Prepares and / or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects.
RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complexAbility to administratively and technically / scientifically review core scientific documentation and feedback gap analysis to customers.Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staffMay strategically plan and perform European centralized submissions and facilitate global submissionsMay provide support on 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.May 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 small meetingsAbility to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervisionAbility to establish and maintain 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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