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hace 4 semanas

Ciudad de México Pfizer A tiempo completo

JOB SUMMARYAn Investigator Initiation Package (IIP) Sr Associate will ensure Pfizer maintains compliance with all requirements relating to release of investigational Product (IP) to clinical trial sites. Members of this team hold responsibility for verifying presence and consistency of required investigator related documents in the electronic Trial Master File facilitating the release of Pfizer sponsored investigational medicinal product.JOB RESPONSIBILITIESAssociate- Quality review of all regulatory IIP essential documents to ensure regulatory requirements are met so investigational product (IP) can be released to clinical trial sites- Continuous Improvement of selected processes relating to IIP submissions and selected drug and non-drug specific projects and related activities e.g. IIP lifecycle records and scheduled IIP regulatory compliance reporting.- Delivery of Clinical Study Portfolio- Support on global/local teams to complete assignments and tasks within a specific task force/project.- Provide support of cross-functional teams as appropriate-- Perform internal QC checks to ensure compliance with all SOP and regulatory requirementsQUALIFICATIONS / SKILLSQualifications:- Undergraduate degree plus relevant experience as below, or-- Demonstrated ability to function autonomously in a matrix environment.- Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems- Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.- Technology: Experience and competency with Clinical Trial and Regulatory software, RRM, Record Management & Tracking.- Fluent in English and Spanish.Associate- Demonstrated knowledge of/experience with Pfizer Clinical Study Portfolio- Demonstrated ability to work with and support a team in a matrix structure- Global perspective within the context of business needs and impactPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory AffairsLI-PFE

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