Amber Solliday Email & Phone Number

Horsham, Pa, Us

Facilitated sessions with cross functional teams and stakeholders to gather key business requirements to analyze and translate into functional and/or user requirements for complex applications and system integrations.Elicited global process harmonization by utilizing use cases and work flow diagram analysis. Provided system demonstrations and training to cross functional users in use of SmartSupplies software applications for PMD (Planning, Manufacturing, Distribution), LRA (Label Routing & Approval), LDP (Label Design & Print), EBR (Electronic Batch Records) and WMS (Warehouse Management System). Key contributor in developing automated system configuration templates for 5 SmartSupplies applications. Ensured compliance throughout the SDLC and demonstrate best practices in all project activities, validation processes and documentation.

Managed project plans for assigned workstreams to ensure project milestones and key deliverables were on target and timelines were met. Authored User Requirement Specifications (URS) document compiled to include core requirements for multiple SmartSupplies system applications.Facilitated meetings with designated Subject Matter Experts and successfully implemented 10 custom reports developed to fulfill specific business needs.

Tokyo, Jp, Jp

Key contributor for SDLC projects and successful system implementations for initial deployment and version upgrades for clinical software applications and integrations.Managed and coordinated enhancements for system interfaces with Interactive Response Technology and Clinical Supply Distribution vendors to ensure development and testing standards were compliant with Shire expectations. Successfully implemented a new process for approving configuration change requests for clinical supply software applications and revised Change Control SOP. Successfully implemented a process to streamline the validation effort for Reports by consolidating tasks and documentation. Created support documentation for the user community to leverage for system guidance, providing the ability to resolve questions. Provided support to end users with troubleshooting and resolving system issues.

Tokyo, Jp, Jp

Managed clinical supply inventory and logistic activities for multiple on-going clinical trials, including depot transfers, site shipments and drug returns. Collaborated with internal and external customers to develop and implement drug supply strategy plan.Managed Clinical Supplies Documentation systems and content ensuring inclusion of essential documentation. Coordinate pre-audit/inspection review.Prepared clinical supply documentation required for the TMF (Trial Master File).Developed clinical supply distribution and return plans with Clinical Supply project manager and contract provider(s).Facilitated the transfer and reconciliation of returned clinical supply drug from investigational sites.Managed clinical supply inventory for projects assigned by interacting with vendors to ensure inventory records were up to date.

Oversaw daily operations in the clinical materials warehouse (36,000 sq. ft.).Supervised and directed employees across multiple workstream activities, including receiving, inspection, staging materials for packaging operations, inventory control, shipping and distribution.Assisted in developing and validating internal electronic system to maintain Clinical Trial Data, including writing and executing user acceptance test scripts.Developed procedures for Clinical Trial Materials System to clearly define processes and ensure system records and documentation are maintained.