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Job Description Senior Specialist Medical Affairs This position is under the supervision of an Associate Director and is responsible for operational activities related to study planning, study execution, and the summarization of results from observational research studies and related activities. Responsibilities and Primary Activities Coordinates the end-to-end process for executing observational or non-interventional research studies in compliance with Good Pharmacoepidemiology Practice and research-related standard operating procedures (SOPs). Plans, initiates, executes, and closes out primary data collection, chart review, database, and molecular epidemiology studies, in addition to other activities (e.g., literature reviews, dossier development, economic modeling support, etc. Collaborates with colleagues across V&I; to support the lead scientists in overall operational support for study conduct. Provides study-level management support,



which includes the execution of appropriate service for approved proposals/scopes of work (including the review of requests for information/proposal, draft scope of work, where applicable), confidentiality and consultant agreements, and subsequent amendments/change orders. Participates in protocol and interim/final report preparation and literature review abstraction and summarization. Coordinates the review and finalization of all vendor documents, such as safety management, data management, communication, project management, and validation plans. Tracks study timelines and deliverables and follows up on action items. Collaborates extensively and troubleshoots issues by providing potential resolutions (when necessary) with internal and external partners, ensuring timely study management and execution. Assists in tracking study milestones and timelines. Liaises with outsourced vendors and cross-functional teams to communicate and oversee project status and/or needs. Provides supplier oversight to ensure alignment with all SOPs and

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📌 Sr. Specialist Medical Affairs (Guaduas)
🏢 Importante grupo
📍 Guaduas