Associate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, Europe

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Associate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, Europe Apply
locations
Reading, Berkshire, United Kingdom
Belgrade, Serbia
Solna, Sweden
Vienna, Austria
Warsaw, Poland
time type
Full time
posted on
Posted 7 Days Ago
job requisition id
R1399127
Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects.RESPONSIBILITIESActs 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 ABILITIESGood 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 small meetings
Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision Ability 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 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
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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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