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Click here or scroll down to respond to this candidateRolling Meadows, IL 60008 LINKEDIN LINK AVAILABLE EMAIL AVAILABLECAREER HIGHLIGHTSBrings nearly 7 years of experience in business analytics and quality assurance in the pharmaceutical, biotech, and medical devices industries, with roles at AbbVie, Abbott, Pfizer, Takeda, and Cardinal HealthImplemented inaugural data documentation efforts at Cognizant, significantly improving contingency planning abilitiesSpearheaded updates on validation protocols and new master data, enabling critical software implementation and infrastructure changes at TakedaKEY EXPERTISEKPI DashboardsAgile, Kaizen & Waterfall methodologyProject ManagementRegression TestingBusiness requirements documentationAuditChange ManagementSAP/TrackWise/Veeva/SharePoint/JiraPROFESSIONAL EXPERIENCEAbbVie Inc. Lake Bluff, ILData Analyst & Project Manager (Contract) May 2022 CurrentAbbVie is a pharmaceutical company boasting the 6th largest revenue in the industry ($58B). Built and oversaw daily reporting for 21 unique reports impacting 30+ employees and informing multiple customized dashboards across organization.Identified organization-wide gap in accessibility of reporting; developed and implemented 4 customized TIBCO Spotfire Analyst dashboards for 10+ teams across company that filled critical gapoCollaborated with multiple departmental leaders to collect and refine dashboard requirementsoCreated 21 customized Excel reports using TrackWise data for Issues & CAPA Management, Audits & Supplier ManagementPinpointed inefficiency in regulatory affairs processes related to terminology gaps; built out centralized RIMS glossary of 186 items that streamlined regulatory affairs and CMC processesOwned business validation testing following Agile Methodology for SolTRAQs (TrackWise) and Veeva system upgrades, including collaborating with multiple teams to identify upgrade needs and customize actual upgrades impacting 500+ usersLed migration of 30 Power Bi data tables from Impala to brand new ODBC Hive platform that improved database response time from an hour to five minutesManaged system migration of 1,000 AbbVie SolTRAQs and 500 Allergan Global TrackWise records into TrackWise Digital (SaaS)Independent Consultant Rolling Meadows, ILBusiness System Analyst (Contract) July 2021 May 2022Provided regulatory affairs and Agile/Waterfall focused business analysis expertise to multiple large medical devices and pharmaceutical companies with revenue of over $1B.Acted as co-owner of business system analytics team, owning, implementing, and leading all sprint cycles in JiraLed cross-functional sprint team of 4 in executing multiple enhancements to Adobe Magento product eCatalogServed as US point of contact for issues related to product ordering system, collaborating across to disciplines to minimize shutdownsManaged sprint team of 5 in collaborating across the business to implement UATsLed all regulatory change assessments on major post-spin-off name change projectHeaded up critical lab documentation project, including pulling data from reports and compiling for multiple teams in VeevaCognizant Rolling Meadows, ILBusiness System Analyst Project Manager January 2021 July 2021Cognizant is an IT services and consulting company with nearly $17B in annual revenue. Recruited to step in mid-project on multiple projects and lead documentation efforts and business system analytics using Jira/Smartsheets in Agile and Waterfall environmentsTasked with creating system functional requirements mid-project for major MES Savigent deployment efforts at all US Cargill Plants; implemented inaugural documentation efforts, transforming contingency planningoActed as representative for 5 plants, identifying functional and non-functional system requirements and verifying and customizing needs based on inputSelected to implement and lead efforts to broaden RWS machine language translation functionality in Veeva RIM, including creating validation test cases, new SOPs for FDA ICH submissions, and product-labeling translation requests; shortened translation wait time from 4+ days to less than 1Takeda Round Lake, ILBusiness System Analyst (Contract) July 2019 December 2019Takeda is one of the top 20 largest pharmaceutical companies with over $21B in annual revenue. Oversaw test cases, UAT/regression testing, and data validation on multiple projects in an Agile environment. Acted as change control owner in TrackWise and Veeva Vault for exTAB SQL database specification updates. Led in-person and virtual technical support.Developed test cases in HPALM, updated project specifications, and executed UAT/regression testing for MES JD Edwards-EBM integrationPerformed data validation, running code in validation and production cycles to identify errors and prevent product delaysOffered hybrid technical support during UAT and Hypercare for Flexbumin plasma production, logging and addressing 40+ issues during 3-day and month-long testing cyclesUpdated and reviewed IQ/OQ/PQ validation protocols and new master data to ensure success of critical new software implementation and infrastructure changesBusiness System Analyst, cont.oCompleted all outstanding change controls, transforming companys change control capabilities, enhancing database efficiency, and minimizing product delaysHCL Technologies Chicago, ILRegulatory Specialist (Contract) April 2019 June 2019Recruited to support regulatory affairs efforts related to Global Medical Devices AdPromo Labeling.Conducted global labeling gap risk assessments in accordance with regulatory compliance requirements and identified need for standardization across labeling practicesDeveloped and implemented labeling requirement documents and master content redlines via TrackWise 8, DOORs, and Nuance Power PDF Advanced to fill gaps across new and existing medical device productsCardinal Health Chicago, ILQuality Regulatory Associate (Contract) November 2018 January 2019Recruited to support regulatory affairs efforts related to product registration at $200B+ multinational health care services company.Conducted analysis of business requirements for legacy products and identified disorganization across product registration; developed and implemented 3 Excel product registration databases for Cordis, Patient Recovery and legacy Cardinal products, transforming efficiency and standardizationAbbott Labs Lake Bluff, ILRegulatory Affairs Project Specialist (Contract) November 2016 November 2018Recruited to support all regulatory affairs efforts across $43B medical device company. Managed import and export of IVDs and biologics blood testing kits from APAC, EMEA, and LATAM; guided TPMs to properly label products exported to the US; and filed CDC, USDA and EPA permitsIdentified major inefficiency related to permit application and approval process and implemented new SOPs related to product labeling, shortening permit approval timeline from 2 weeks to 1 dayIncepted and implemented R&D documentation initiative, successfully collating documentation for 100+ products to prevent future inefficienciesApproved import and export of IVDs and biologics for clinical trials, semi-finished and finished products to APAC, EMEA, and LATAM by creating CUCs, attestations, FDA declarations, and health certificatesManaged project metrics for import, export, and global product registrations for 100+ productsCreated legal documents for global registration of productsResolved MDM issues to create multiple master databases and investigated regulatory compliance emerging issues while supporting FDA audits and resolving FDA noticesManaged the RIMS databases of IRIS and FOCUS for US, global regulatory affairs and authorized distributers, performed validation following Waterfall MethodologyPfizer Lake Forest, ILQuality Engineer Regulatory Affairs Specialist (Contract) October 2015 November 2016Developed and implemented strategies across $12B pharmaceutical and medical devices company to eliminate inefficiencies, implemented serialization with Track & Trace and new labeling QR codes.Identified superfluous spending related to packaging; collaborated with bulk carton vendors and developed mater list of critical manufacturing data that contributed to elimination of 200 packaging sizesCreated strategy and performed risk assessment to implement obsolescence changes for 5,000 productsDeveloped DCR / DIR packages, updated BOM, and conducted documentation impact assessments for manufacturing specification changes in collaboration with multiple departmentsLed team in creating new GTINs for serialized products in accordance with GS1 standardsCreated 32 container, closure, and seal specification documents for FDA submission following FDA eCTD and ICH guidelinesLed and trained sales enablement team in approving sales enablement requests in SAP Sales & Distribution for medical devices and pharmaceutical products and in use of SAP DMS systemGenerated daily sales metrics reports for product launch status for Commercial QualityEARLY CAREERKraft Foods Project Manager Validation Analyst 2014 2015 Diageo Project Manager Specification Analyst 2014SKILLSLanguage: Urdu, English, & Hindi Technical: JD Edwards, Smartsheets, TrackWise 8, & Veeva Vault/RIMSPROFESSIONAL AFFILIATIONSMember Regulatory Affairs Professionals Society 2016 Present Member American Chemical Society 2016 PresentEDUCATION & CERTIFICATIONSUniversity of Illinois at Chicago Bachelor of Science in Biology and Psychology SAP Certified Change Coordinator SAP 2015 |
