IQVIA Regulatory Affairs Officer 2 in Montreal, Canada
Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Independently provides regulatory support for more complex projects.
• Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate.
• Competently writes regulatory and/or technical documents with minimal review by senior staff.
• Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues.
• Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate.
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• May present to clients at bid defence meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff.
• May write new regulatory SOPs, and/or propose revisions and/or act as reviewer for regulatory SOPs, as assigned and appropriate.
• May be involved in a Regulatory and/or IQVIA Initiative.
• Performs other tasks or assignments, as delegated by Regulatory management.
• Other Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience
• High School Diploma or equivalent plus at least 9+ years experience* (*or combination of education, training and experience)
• Demonstrates comprehensive regulatory or technical area of expertise
• Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
• Strong software and computer skills, including MS Office applications
• Demonstrated skills in chairing small meetings
• Ability to work on several projects, retaining quality and timelines and can prioritise workload with minimal supervision
• Ability to propose revisions to SOPs or suggest process improvements for consideration
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at 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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