IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
This role is a great opportunity for an experienced regulatory professional with broad regulatory experience and expertise to work with the world's leading CRO. This position requires a demonstrable knowledge of operational experience in European regulatory affairs within the service industry or biopharmaceutical companies.
Manages a regulatory and/or technical project, for both internal and external clients, as appropriate. Provides strategic regulatory and/or technical consultancy on a variety of projects.
• Acts as a Lead Regulatory Professional on non-clinical writing or technical project, with limited guidance from senior staffusing experience and initiative to generate new and unusual document types to meet customer requirements.
• Provides strategic regulatory and/or technical consultancy on a variety of projects and provides senior review andguidance for most documents prepared by junior colleagues.
• May act as a Project Manager for a stand-alone project, with full project management responsibility.
• May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routineprojects, out of scope activities and potential budget efficiencies. Deliver business development presentations tocustomers with confidence and detailed knowledge, as directed.
• Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges thatare acceptable to IQVIA and customers, thereby consistently receiving positive customer feedback.
• Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits.
• May design training materials and deliver training externally and internally.
• May represent region or site on a regulatory, technical or cross functional Initiative.
• Performs other tasks or assignments, as delegated by Regulatory management.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Extensive experience in regulatory and/or non-clinical writing
Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
Strong software and computer skills, including MS Office applications
Sets a positive example to more junior colleagues relating to a professional manner, positive attitude and communication style with customers and colleagues
May take calculated risks when making decisions, seeking guidance from Regulatory management, as appropriate; demonstrates autonomy and initiative, as appropriate
Ability to earn respect from peers in other operational groups
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Degree in life science-related discipline (toxicology preferred) or professional equivalent plus at least 6 years relevant experience* including 4 years regulatory experience or high school diploma plus 10 years relevant experience* including 6 years regulatory experience (*or combination of education, training and experience)
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.