• Member of the Technical Operations team, responsible for contributing to the Gene Therapy (GTx) project
• Authored/reviewed Validation Protocols, Standard Operating Procedures (SOP) and Master Batch Records (MBR)
• Referenced technical reports, production documentation, batch records and procedures to obtain information to design raw material matrices and support regulatory filing
• Collected and provided Certificate of Analysis/Certificate of Conformity to the Global Regulatory Affairs Team for various raw materials and equipment used during associated Process Performance Qualification (PPQ) activities
• Performed leaflet data verification tasks based on review of physical and electronic data sources, in support of Biologics License Application (BLA) submission
• Participated in cross-functional teams, including Drug Product GTx Manufacturing, Quality Assurance, Technical Operations, Global Regulatory Affairs, to coordinate activities and drive timelines for BLA submission

• Responsible for the creation of Standard Operating Procedures (SOP), Job Aids (JA), Work Instructions (WI), and Master Forms (MF) in accordance with site document guidelines and cGMP
• Identified and connected with Subject Matter Experts in various areas to align on document content during the Draft, Redline and Approval phase
• Routed procedural documents for official review and approval in the Veeva Vault content management platform
• Worked with Document Owners to submit Document Change Control requests
• Ensured that project deliverables are being met according to established timelines for manufacturing activities
• Provided SOP project updates on behalf of Plant Engineering & Maintenance and Warehouse & Logistics teams
• Aligned with the Learning & Development and Document Control teams to share important updates across various departments, contributing to process improvement

• Key member of a global team that delivered 138% YoY results. Collectively we delivered $640M of annual revenue, with a focus on Data, Analytics, and Digital Transformation
• Responsible for global operations management for Software and Services
• Participated in a WW SAP business focused on key products such as HANA and Lenovo Intelligent Insights with Data Hub
• Established project deliverables, in coordination with senior program and product managers
• Facilitated weekly project meetings and monitored/updated project plans/PORs
• Performed light Chief-of-Staff activities to include direct executive support and team alignment
• Supported cross functional team meetings with engineers, product managers, marketing, and salespersons
• Responsible for maintaining a relationship with key stakeholders, executives, strategic alliances, and partners
• Collaborated with senior executives, Procurement and Legal departments to deliver on administrative tasks

• Handled all meeting coordination and logistics
• Experience with Workday, Concur, Egencia, Skype and most Microsoft systems
• Supported various executives and their key team members as needed
• Coordinated complex calendars for internal associates and external partners
• Provided around the clock support and coverage to accommodate international schedules
• Utilized the SAP Ariba procurement system to create purchase requisitions
• Familiar with asset management and CRM systems
• Assisted with the planning and coordination of company events

• Conducted detailed consultations with potential clients in need of legal help
• Worked across various practices including Social Security, Disability, Worker's Compensation, Wills & Estates, Nursing Home Neglect & Personal Injury
• Management of national legal campaigns to drive business
• Worked in partnership with external law offices
• Processed referrals of potential clients
• Maintained consistent and direct communication with Attorneys
• Provided comprehensive information to attorneys to assist with client needs

• Managed a caseload of 80 clients and worked to obtain payment where entitled
• Assisted attorneys in the negotiation process and conducted initial client meetings
• Communicated with clients regularly answering questions and addressing concerns
• Regularly met with new clients to explain legal services contracts in entirety
• Filed claims with various insurance companies
• Requested medical records and bills that supplement and support claims
• Analyzed and summarized medical records and medical bills for demand letters
• Prepared detailed demand letters/packets to be sent to insurance companies
• Obtained and itemized health insurance liens, Medicare information and worker's compensation
• Assisted clients with property damage and diminished value claims
• Dispersed final payment to the appropriate parties upon settlement

• Completed appeals for Social Security, Disability and Supplemental Income
• Prepared and requested medical records from various entities
• Requested additional important documentation from various providers regarding Worker's Compensation and Personal Injury Claims
• Prepared requests for billing statements for personal injury claims
• Developed case summary drafts
• Maintained various forms of communication with clients