Capabilities
Types of Roles
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Program & Project Planning
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Resource Allocation & Management
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Budget Establishment, Analysis & Tracking
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Project Scope Definition
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Mergers, Acquisitions & Divestitures
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Functional Leaders & Team Members
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Success Measures & Metrics (Dashboards)
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Assessments
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Deviation & CAPA Management
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Drug Quality & Security Act (DQSA)
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Drug Safety
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Process Design, Harmonization & Validation
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QA/QC
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Remediation Services
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Unique Device Identification (UDI)
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Design History File (DHF), Drug Master File (DMF) & Device Master Record (DMR)
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Clinical Trial Phases I-IV
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Product Development Process
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Total Quality by Design
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Drug Formulation
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Drug Delivery
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Drug Stability
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Process Development
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Design Controls
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Pipeline & Portfolio Management
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Risk Management
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FDA & EU (483 Observations, Warning Letters, Consent Decrees) Remediation
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Submissions (Premarket Approval PMA, 510(k), CE Mark, INDs, ANDAs) & Compliance
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Technical File & Design Dossier Preparation
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Labeling, Packaging, Advertising & Promotional Materials
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Health Economics & Outcomes Research (HEOR)
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Compliance
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Pharmacovigilance
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Medical Safety
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Medical Liaisons
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Information Services
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Communications
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Education
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Business Intelligence
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Change Management
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Customer Relationship Management
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Enterprise Document Management System
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Electronic Laboratory Notebook
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ERP (SAP, Oracle)
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Laboratory Information Management Systems
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Manufacturing Execution System
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PMO & PPM
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Quality Management System
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Operations & Manufacturing Strategy and Process Excellence
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Technical Transfer
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Innovation & Product Development
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Sourcing and Procurement
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Integrated Planning & Analytics, Logistics, Quality and Supplier Compliance
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Knowledge Capital
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Implementation Accelerators
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Analytics & Mobility
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Control Towers
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Contract Manufacturing
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Six Sigma
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TPM
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Sales Strategy
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Speaker Program Management
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New Channel Development
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Operational Efficiency
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Product Marketing
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Market Technology Review & Assessment