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Job OverviewIndividual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.Essential Functions 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 many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments; Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; 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 defense meetings by phone or in person; May act as reviewer for regulatory standard operating procedures, as assigned and appropriate; May prepare and deliver regulatory training to IQVIA small groups or individuals; Performs other tasks or assignments, as delegated by Regulatory management;Qualifications Bachelor's Degree Degree in Lifescience or related discipline Req Or Master's Degree Degree in Lifescience or related discipline Req At least 3-4 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Possesses a specific regulatory or technical expertise; Good, solid interpersonal communication (oral and written) and organisation skills; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable; Demonstrates self-motivation and enthusiasm; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Applicable certifications and licenses as required by country, state, and/or other regulatory bodiesAt 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 67,000+ 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 an EEO Employer - Minorities/Females/Protected Veterans/DisabledIQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workdayrecruiting@iqvia.com to arrange for such an accommodation.At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
