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)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

　　IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

　　IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

　　To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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