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Develop, implement, and maintain phase-appropriate Quality Management System (QMS) through the development, review and approval of documentation including policies and standard operating procedures (S...
Assists with regulatory intelligence by monitoring the global regulatory publishing environment and providing regulatory summaries and dissemination of critical materials as appropriate...
Provide statistical guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves...
Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources.
Provides internal data monitoring and Quality Assurance checks for compliance with GCP (Good Clinical Practices) SOPs (standard operating procedures) and Sponsor data requirements ...
Develop and implement phase-appropriate stability strategies for PBI’s allogeneic CAR T platform and AAV gene therapy programs to support clinical development and commercial registration...
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities. Ability to manage multiple priorities within various clinical trials. Ability to reason i...
Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with cli...
Drive the annual Sales Incentive Compensation planning and design process for creating the compensation plans and programs for the sales organization that incorporate quotas, accelerators, bonus progr...
The System Administrator will provide on-going technical assistance, handling incident tickets on a priority basis, software configuration / customization assistance including, but not limited to: scr...
The job of the System Administrator is installing, operating, and maintaining physical/virtual operating system workstations and servers in support of business processing requirements...
Lead the Quality Control team (Quality Associates, Quality Technicians, Quality Tech Supervisor, and QC/ Quality Associates) providing leadership and guidance for quality issues that occur during in-p...
Prepare the Technology Centre (TC) Mission & Vision, TC related part of Roles and Responsibilities document and Competence Profile (in cooperation with the respective Product Group Technology Manager...