Job Description
Position Summary: Provide support to develop and implement data repository and analytics tools in pharmaceutical environment. Essential Duties & Responsibilities:· Analyze business needs for data and analytics to support regulatory filings· Identify, classify, and map data sources· Define data lineage diagram from data source to analytics ready datasets· Establish data curation requirements to help organize, clean, manage, and maintain data so it can be used reliably for analytical use cases· Support data integration, architecture design, and transformation activities· Develop data governance standards to comply with company and industry best practices· Lead requirements, design, testing, and go-live documentation· Coordinate test planning, execution, and issue resolution· Provide support for training business teams for Go-Live· Support training, deployment readiness, and project team communication Qualifications:· Bachelor’s Degree o Minimum of 5-10 years of experience in IT working in the role of business and technical analyst with the focus on data, business intelligence, and analytics projects o Experience working in Biotech/Pharma (Regulated Industry)o Experience with developing requirements, design, and testing documents. o Hands-on experience with data analysis and reporting in support of Pharmaceutical GMP environment.o Demonstrated experience managing lifecycle documentation and validation in FDA-regulated environments.o Experience with helping lead data analysis and engineering projectso Ability to work independently, meet tight timelines, and collaborate cross-functionally · Knowledge: o GxP, Pharmaceutical Manufacturing and Quality Data (GMP data), Data analysis and reportingo Experience working with analytics (Python, R, Excel, Tableau, Spotfire, other reporting and analytics for manufacturing process industries)o Experience with database (SQL) and ETL developmento Experience with cloud environments (AWS, Azure)· Skills: o System Support/System Administration, Communications, Project Management, Training, Computer System Validation, and Business Requirements Documentation
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