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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).
• Deliver regulatory training/presentations as required, internally or externally
• May mentor junior colleagues and engage in department knowledge sharing
• May perform additional tasks as deemed appropriate by Line Manager

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Good understanding of the regulations, directives and guidance supporting clinical Research and Development
• Demonstrates comprehensive regulatory/technical expertise
• Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
• Strong ownership and oversight skills
• Demonstrated skills in chairing meetings and working on initiatives
• Ability to work on several projects, retaining quality and timelines and can prioritize workload
• Ability to propose revisions to SOPs or suggest process improvements for consideration
• Strong mentoring skills, helping junior colleagues and setting a positive example
• Innovative and solutions-driven
• Strong skills in establishing and maintaining effective working relationships with co-workers, managers and clients
• Strong software and computer skills, including MS Office applications

MINIMUM 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)
• EU-CTR knowledge & experience
• Global CTA submission experience

PHYSICAL REQUIREMENTS

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Travel might be required

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This role is not available for UK visa sponsorship

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