Sarah Chang, Pmp Email & Phone Number

Alameda, California, US

Alameda, California, US

Alameda, California, US

Foster City, CA, US

• Manages complex processes across all functions, collaborates effectively with clinical protocol teams to provide inputs on the packaging and labeling configuration/options
• Successfully leads a GMP system development and implementation project with Oracle Agile Product Lifecycle Management web-based softwareo Works as the Business System Process Lead for a multidisciplinary team of.
• Responsible for people management, including employee skills development and goal setting, coaching and mentoring, performance evaluations, job related or interpersonal issues resolution, and resource efficiency.

Foster City, CA, US

• Worked collaboratively with Clinical Operations, Formulation Process Development, Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing, and Project Management partners to develop optimal.
• Generated clinical trial labels, collaborated review and approval activities with Regulatory Affairs/Clinical Operations/Qualified Person/Quality Assurance, and ensured all global supply labels were filed accurately to.
• Established and maintained the relationship with third-party vendors of GMP supply services (including system implementation, label printing, packaging and labeling, translation, and regulatory review)
• Partnered with Quality Assurance to resolve quality-related issues with label printing/labeling vendors in a timely manner and develop effective corrective and preventive actions

Boston, MA, US

• Successfully managed the production and distribution of all clinical trial materials to enable the advancement of the DUROS product from Phase I to Phase III
• Managed four Phase III global studies for over 500 sites in 32 countries and developed strategic plans to ensure the optimal amount of drug supply, monitoring expiry dating and the study enrollment rate for all sites.
• Forecasted and maintained project specific budgets, provided inputs for department budget planning, resolved various invoices issues, and recovered credits from CMOs
• Supported on IRT system development and implementation activities, utilized IRT to manage inventories at depots and sites to ensure on-time delivery
• Worked as the liaison between all levels of stakeholders (Clinical, Regulatory, QA, CMC, Manufacturing, and Product Development) to ensure proper communication for establishing CMC manufacturing plan, mitigating.
• Monitored and scheduled manufacturing activities and resources daily to secure sufficient resources for the team to complete assigned tasks in a timely manner

Seattle, Washington, US