- BeiGene (Emeryville, CA)
- …study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... quality, within agreed timelines and budget + Acts as regional lead for multiple studies across an...meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional … more
- IQVIA (Berkeley, CA)
- …FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation of clinical studies including: * Manages projects of full scope ... responsible for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and compliance with… more
- BeiGene (Emeryville, CA)
- …+ Works cross-functionally to ensure proper planning of inclusive clinical study protocols, providing feasibility feedback on regional site selection and ... **General Description:** Reporting to the Head of Americas, Clinical Operations, the Director - Clinical ...to hold composure, be engaged and present adeptly to senior BeiGene leadership when needed + Scientific acumen -… more
- BeiGene (Emeryville, CA)
- **General Description:** The Senior Manager of R&D Quality Systems, Strategy, and Excellence (Process & Procedure) is responsible for implementing and maintaining a ... implementation across teams. + Build strong partnerships across departments (eg, Clinical Operations, Regulatory Affairs, R&D) to ensure that quality is embedded… more
- BeiGene (Emeryville, CA)
- …including, but not limited to, global regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... affairs departmental and cross-functional influence and acts as an advisor/liaison to senior management and project teams to plan, evaluate and recommend regulatory… more
- BeiGene (Emeryville, CA)
- …but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory ... the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to...US and Canada. + Supports the NA solid tumor regional team to negotiate with the US FDA as… more
- BeiGene (Emeryville, CA)
- …but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory ... the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to...the US and Canada. + Supports the NA hematology regional team to negotiate with the US FDA as… more
- BeiGene (Emeryville, CA)
- …including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... are met including the review global submission documents in support of clinical trials and marketing applications, and their amendments to support investigational… more