- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external ... such as IB, protocol, CSRs, IND and NDAEnsure GLP regulated activities for computer systems are in place and...to ensure a compliant ready state of operation.Ensure that CRO / Vendor quality events/ incidences are adequately reviewed and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …need someone with a minimum of 8-10+ years of experience with outsourcing regulated bioanalytical assays and oversight of CRO activities required.** Hands-on ... We are seeking a highly motivated ** Director ** to join to our Bioanalytical Sciences team....Contract Research Organizations (CROs) + Providing scientific support to CRO efforts in design, development, and implementation of a… more
- IQVIA (Durham, NC)
- …and coordination of resources for the Immunoassay Services Laboratory. The Senior Director interacts with clients, the project management organization, Managers, ... The Senior Director / Director of Bioanalytical Laboratory...areas. + Provide oversight and guidance to the Project Management Organization, Data Management , Technical Writing, QC… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Bioanalysis - 2406211500W **Description** Johnson and Johnson is currently seeking an Associate Director , Compliance, located in Springhouse, ... their potential. At Johnson & Johnson, we all belong. As an Associate Director of Compliance in Bioanalytical Discovery and Development Sciences (BDDS), you will… more
- Takeda Pharmaceuticals (Columbus, OH)
- …best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and Marketed ... enables you to engage in meaningful work? Join us as an _Associate Director - Nonclinical Regulatory Writer_ _and Submission Support_ reporting to the Nonclinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …industry best practices. + Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external ... IB, protocol, CSRs, IND and NDA + Ensure GLP regulated activities for computer systems are in place and...a compliant ready state of operation. + Ensure that CRO / Vendor quality events/ incidences are adequately reviewed and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Clinical Supplies & Comparators (Clinical Development Services Procurement) at the Associate Director level, plans and leads category projects for a clearly defined ... savings target and leads category projects, spanning sourcing projects, demand management and process re-engineering, as well as managing sub-category specific… more
- Charles River Laboratories (Mattawan, MI)
- …quantitative analysis of drug in body fluids and tissues from non- regulated and regulated studies including preclinical safety evaluations, ... using appropriate software + Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas + Demonstrate effective… more
- Charles River Laboratories (Rockville, MD)
- …Rockville & Hanover EHS&S inspection program using Enablon, the CRL EHS&S management system. Support the corporate EHS&S assessment team in their assessment of ... * Report and work directly with the Rockville Site Director with a dotted line to the EHS&S Business...and conduct reviews at appropriate intervals with facility senior management . * Consult with CRL management and… more
