Continued focus on Professional Services initiatives by supporting agile backlog, software release change management, and process improvements. Successfully led the pilot rollout and change management of cloud solution migration and scheduling tool.

Supported agile team by participating as business SME for backlog prioritization and new request submission. Streamlined new product release coordination with readiness and professional services.

Responsible for the day-to-day operations of the Order-to-Cash support team. Monitored project health and ensured completeness and timeliness of testing and go live activities. Provided mentorship, oversight, and direction to employees, resulting in a cohesive team that successfully completed projects on time and within budget.

Program Manager for Project STAR (Software Transformation to Achieve Results), consisting of 5 workstreams and 13 sub-projects.

Managed mobility tool project, including the pilot and full rollout of the tool that allows the field teams to capture implementation activity from their mobile device. Provided ongoing support to the Order-to-Cash business by leading SAP enhancements and break/fix issues, and monitoring GMB.

Created and manage systems database which stores and reports customer and contract details. Monitor maintenance contracts for impending expiration dates and provide notification of unused/available services under current agreement. Prepare reports for marketing, sales, contracts and logistics groups.

Created study specific tracking tools and timelines providing line-level management of Clincial Operation's tasks related to site initiation and activation. Managed Clinical Trial Management System. Worked closely with Clinical Operations department and multiple CROs providing follow-up on action items, while tracking site initiation and activation, as well as screening and enrollment.

Played a key role in the successful submission of a Marketing Authorisation Application in Europe. Created and manged the overall MAA timeline, and served as lead Regulatory editor of the CMC section, providing document revision assistance, as well as oversite of the on-site production QC. Planned and attended several on-site US / EX-US Regulatory Agency meetings. Created and managed global development timeline, as well as department timelines. Prepared and supported compilation of Regulatory submissions.

Assisted with preparation and execution of FDA Inspection. Participated as scribe for a successful FDA PAI Inspection and coordinated document preparation for a clinical inspection. Planned all US and EX-US Regulatory Agency meetings. Provided on-site logistical support. Provided assistance with both eNDA and IND submissions.

Assisted with the successful fully electronic New Drug Application (eNDA) filing participating in the eNDA sub-team providing document QC and submission compilation. Coordinated FDA meeting travel including on-site support.

Entered material and inventory control transactions, label copy approval routing, packaging design coordination, purchasing, managed company-wide office and stationary supplies. Established policies and procedures and maintained the office operations, policy and procedures manaul, as well as departmental SOP manuals.

Tradeshow event coordination, on-site logistics, lead follow up. Communications department literature maintenance, promotional and graphic inventory, catalog and publication insertion order processing, document review for trademark and legal claims, management of project and events calendar. Document, artwork, and packaging approval routing.