- Legend Biotech USA, Inc. (Raritan, NJ)
- …Actions (CAPA) process, and is responsible for ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA program for the CAR-T ... and lead CAPA site governance program . Drive continuous improvement of quality systems processes. Implement processes to ensure compliance with current Good… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... control and deviation processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This position is also responsible for… more
- Merck & Co. (Rahway, NJ)
- …and inclusion so everyone can bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's ... and robustness across organizational deliverables.- In this role, the DSCS Digital Program Manager will provide strategic and tactical direction and partner… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, company policies and procedures and-with quality standards internally and externally.Under the oversight of the CRD(Clinical ... individual is responsible to-manage/oversee a team of CTCs(Clinical Trial Coordinator).As line manager the role is critical to continuously develop future talent by… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The ... ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.Reviews… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … systems .Company Sponsored Studies (CSS) and Medical Access/Expanded Access Program (MAP)/(EAP)Support the oversight of the overall global oncology review process ... support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical… more
- Aequor (Thousand Oaks, CA)
- …skills: Strong excel, PowerPoint, and Smartsheet experience. Summary: The Project Manager Global Partnership Supply, under the supervision of the Manager ... identifying resource needs, performing thorough review; and escalating functional, quality , timeline issues appropriately. Responsible for tracking key project… more
- Aequor (Raleigh, NC)
- …MS PowerPoint and MS Excel skills; understanding of systems for sharing and collaboration; excellent communication skills to work with cross- program resources. ... Remote Position - Flexible Hours Manager is open to seeing candidates with a...high-level, complex non-technical projects within the constraints of scope, quality , time, and cost, to deliver specified requirements, including:… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... define priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with publishing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... the validation team in the establishment and maintenance of validated systems . Coordinate technology transfer activities in support of commercialization. Serve as… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports of all calibration and maintenance ... to develop, document, and implement new measurement methods and test systems .Demonstrated knowledge of programming languages in support of instrument automationGreat… more
- Novo Nordisk Inc. (South Houston, TX)
- …Education Program strategy. Interacting with health system KOLs, providers, quality , care coordinators, advanced practice providers, and the like to identify ... the system population. Internally, the Diabetes Educator reports to the Health Systems Diabetes Educator Manager (HSDEM). The Diabetes Educator primarily aligns… more
- Eisai, Inc (Nutley, NJ)
- …at least 5 years of enterprise-level governance and management.Certified Information System Manager (CISM), Certified in Risk and Information Systems Control ... review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory, commercial,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project. As a project ... manager this position is accountable for partnering with the...the project environment to address gaps that impact the program /project.Manages the planning and use of program /project… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Catalent (Harman, WV)
- …and eight additional suites coming online.Reporting to the Vice President and General Manager , the Senior Director Supply Chain directs all facets of supply chain ... and financial costing. This includes the deployment of common systems , improved processes and advanced technology to drive continuous...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Carolina Theatre of Durham (Durham, NC)
- …cash management, vendor invoices, donations, payroll and fixed assets. o Ensure the quality and comprehensiveness of the month end closing process. o Ensure proper ... Investment Policy. * Supervise HR processes: o Supervision of HR/Office Operations Manager o Payroll, Benefits, Compliance o On-Boarding * Manage relationship with… more
- The University of Vermont Health Network (Plattsburgh, NY)
- …Specialist Infection Disease, Pharmacy Residentss and Pharmacy Interns. The Clinical Pharmacy Manager will act as the Pharmacy Residency Program Director; ... GENERAL SUMMARY: The Clinical Pharmacy Manager is responsible for the design, planning, implementation...5 core health care competencies of interdisciplinary team work, quality improvement, evidence based practice, patient focused care and… more
