- BeOne Medicines (Emeryville, CA)
- …Functions of the Job:** + The individual should collaborate internally with Quality , Supply Chain, Regulatory Affairs and externally with CDMO to ensure timely ... commercial drug product manufacturing** + Collaborate with supply chain and quality to establish technical management to routine commercial manufacturing and… more
- BeOne Medicines (San Mateo, CA)
- …evaluations. + Develop and enforce data governance standards, including data quality , security, and compliance through automation. + **Innovation & Rapid ... data models (CDISC, SDTM, ADaM), and typical data challenges ( quality , lineage, integration, governance) is highly desirable **Supervisory Responsibilities:** No… more
- Turner & Townsend (San Francisco, CA)
- …future spending for a portfolio of $1B+ value 5. Ensure budget and quality compliance and participate in Value Engineering exercises to ensure projects are completed ... the team on various aspects of Cost Management to ensure high quality and standards are maintained across the organization. **RELATED OCCUPATION:** Consultant or… more
- AbbVie (South San Francisco, CA)
- …talent and organizational skills to evaluate target opportunities and produce high quality analyses. Ability to drive projects to deliver timely results and follow ... through on commitments. + Strong communication skills to effectively communicate business strategies and capabilities internally and externally, present individual and team recommendations clearly and concisely, and promote cross-functional communication. +… more
- BeOne Medicines (Emeryville, CA)
- …and data from internal sources and external datasets; ensure data quality and consistent use of definitions/assumptions across teams + Provide commercial/business ... case assessment to inform pipeline programs' go-no-go and critical investment decisions + Collaborate with cross-functional teams to establish Target Product Profiles and develop market positioning strategies for early-stage pipeline programs + Collaborate… more
- BeOne Medicines (Emeryville, CA)
- …CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-approval applications. + Develop ... regulatory strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre-meeting packages, and interactions with Heath Authorities as needed for the assigned project + Work collaboratively with cross-functional… more
- BeOne Medicines (San Mateo, CA)
- …design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements. + Collaborates with the statistical programming staff ... to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements. + Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Applies and implements… more
- AbbVie (Irvine, CA)
- …involving Tissue Management Science, Product Development, Clinical, Medical Affairs, Quality , Regulatory, Health Economics Outcomes Research, Global Access & Pricing ... Reimbursement, Operations. This individual is responsible for generating a variety of commercial inputs: identifying and gathering insights through market research and KOL management, leading innovation councils, user needs documentation, target product… more
- BeOne Medicines (San Mateo, CA)
- …+ Champion and support process improvement initiatives and optimize efficiency, quality and performance. + Collaborate with teams to deliver on commitments ... to the organization and to patients. **Essential Functions of the job:** + Responsible for planning and executing projects in accordance with program development strategy. + Develop, track, and manage the progress of the global development project to defined… more
- Taiho Oncology (Pleasanton, CA)
- …the external vendors and overseeing all processes to ensure efficient and high- quality data production. + Collaborating closely with related departments such as data ... management, biostatistics, clinical operations etc. to ensure full and effective integration of PK dataset within TOI activities. + Provide support of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes.… more