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IQVIA
,
Reading, Berkshire
Reg Affairs Officer 2 - Clinical Trials
Overview
Job Description
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. PURPOSE Prepares and/or reviews regulatory submissions to support clinical trial. RESPONSIBILITIES Acts as a Regulatory Team Leader on more complex projects, which may include technical writing. Prepares and/or reviews regulatory documentation in area of expertise, as appropriate. Establishes relationships with customers. Understands the Scope of Work, deliverables and management of budget for any given project and manages workload 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 on complex regulatory processes at large full service bid defence meetings by phone or in person. May act as reviewer for regulatory SOPs, as assigned and appropriate. May prepare and deliver regulatory training to Quintiles small groups or individuals. Performs other tasks or assignments, as delegated by Regulatory management. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Possesses a specific regulatory or technical expertise Good, solid interpersonal communication (oral and written) and organization skills Strong software and computer skills, including MS Office applications Demonstrates self-motivation and enthusiasm Demonstrates negotiation skills and is confident in making decisions with minimal supervision Ability to work on several projects, retaining quality and timelines Ability to follow SOPs consistently; provides independent thought to assist in process improvements MINIMUM REQUIRED EDUCATION AND EXPERIENCE Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience desirable however less experience considered. Join Us 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.