New York City Metropolitan Area
Project Manager and Senior Manager who leads teams and complete projects in the pharma and medical device industries, covering all facets of projects from a financial and technology perspective. Routinely liaise with business units to reduce risk and inform developers and other IT staff what is needed to roll out products, services and websites. ACCOMPLISHMENTS • Analyze project scope and risks, and implement corrective actions to assure solution delivery; create scope change request when needed. • Full lifecycle covering requirement collection, RFP creation, SOW project contract, weekly contract maintenance/payout, coordinated product release schedule and project closure. • Weekly and monthly reporting of team’s project and maintenance accomplishments using Power Point and Tableau tools for management and budget tracking. Weekly PMO corporate reporting on team efforts and risk escalation with governance board. • Assure updates and projects follow CFR Part 11(IQ, OQ and PQ) compliance though review and meetings • Global Supply chain exposure of process planning and full cycle of creating of finished goods • Managed the process flow of an external creative agency, building assets and working with an offshore partner to implement the updates with a business UAT testing cycle at the end. • Key compliance remediation on sites: dshuddel.com and depuysynthesudi.com (GxP, 21 CFR), complete Drupal rewrite and GxP data migration to J&J hosting. (65,000 medical device database/Web site) • Supported other brands, such as Chapstick.com, Emergen-C and AdvilAide.com under Drupal
Work with internal CSL departments/regions requiring technology resources on project and operation activities. Assist in demand collection, cording resource and demand planning on platform/system modernization efforts. • Use of SharePoint forms to collect business needs and track progress • Creation of Power BI dashboards for information and status distribution • Scope control and budget prioritization tracked and global goals are aligned
Implement Aetion RWD/RWE system and validate data/function to benefit the Medical Affairs and research departments. Work with external vendor to assure corporate compliance and data policies on implementation. • Work with internal teams on requirement collection, RAID Tracking and UAT/validation scripts • Engage Aetion vendor to address requirements, testing and installation needs • Data contract tracking and validation on real world data sources and cohorts • Scope control and budget priority tracked/spend reported through Clarity-PPM (ERP)
Implement data system and validate lab equipment installs to benefit the clinical research department. Work with external vendor to assure corporate compliance and data policies on equipment and data capture. • Activate the long term POC system to support Clinical Trials and advance automation/data capture. • Validate and integrate a ThemoFisher Orbitrap analyzer into to lab environment. (GLP/non-GLP) • Weekly PMO reporting on efforts using MS-Project/Gant and active RAID logs • Participate on external vendor assessment study CDMS system alternative and upgrade path. • Expand Cloud NAS/HPC storage for model simulation and AI computing
Project tracking of workloads and business requested program/tickets for new product changes and modification in medical insurance policies and HIPAA guidelines • Work with development team to prioritize project work though life cycle and schedule development sprints. • Focus on priority customization to Asembia1 pharmacy and interfaces for new clients and product releases • Bi-weekly report generation of priority JIRA ticket/epics in to Excel, SmartSheet and CSV format for executive reporting, decision making and resource leveling. • Integration work on external clients support AERS call center to Asembia hosting
Worked with internal business groups and external creative partners to deliver Medical Affairs Portal for HCP interaction and drug education promotion. Second effort on HCP Master Data and FDA Sunshine Reporting. • Medical Affairs portal buildout for HCP audiences, listing Congress detail, pipeline and product details. Including collection of HCP details for research/study proposals • Sunshine Transparency Reporting implementation with expense vendors and master data process analysis using Tableau/Power BI • Grant Research awards tracking and data analysis and modeling proposals • User of JIRA, Confluence, PowerPoint with SmartSheet for project tracking and executive reporting • Working with external vendor to improve data quality and reporting accuracy • RFP creation and vendor bid processing with scoring