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Recently posted jobs
Pharmaceutical
Prepare, review, and support medical device registration submissions and post-market activities per Health Canada. Manage document extraction, change control, labeling, authorizations, and tracking. Ensure cGDP compliance, coordinate cross-functional teams, respond to inquiries, maintain regulatory dossiers, and support tactical issue resolution.
Pharmaceutical
Lead data management for clinical trials including database setup, eCRF specification, validation/edit checks, testing, data review/reconciliation, SAE reconciliation, database lock/unlock, vendor data transfers, training, and DM documentation to meet timelines and quality standards.
16 Days AgoSaved
Pharmaceutical
Develop, validate, and maintain statistical programs (TLFs) using SAS and R. Perform data manipulation, analysis, visualization, and QC. Collaborate with biostatisticians and data management, ensure CDISC and regulatory compliance, and support submission documentation.
Pharmaceutical
Manage biometrics project teams from study start-up through closeout, coordinating Data Management, Biostatistics, Statistical Programming and Medical Writing. Serve as client/vendor liaison, create timelines, lead meetings, manage financials and contracts, identify risks and change orders, support RFP/RFI and governance, and drive cross-functional collaboration and issue resolution.
