- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … setting, to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead on generation of ... reports and co-authoring primary and secondary sections of regulatory documents. The Manager , Clinical Pharmacology is expected to identify, generate and execute… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has ... assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global ... in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to ... quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking ... sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study...allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in… more
- Novo Nordisk Inc. (San Antonio, TX)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical trials, in line with established targets and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; ... Delivers all relevant services/tasks in support of the planning and execution of quality driven clinical trials in line with established targets and including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …eg routine networking through membership in industry association(s). Essential Functions Sales Operations Partner Drive value creation and link quality to ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... the Quality Unit and could include all or some aspects of the Quality function.The Product Development QA Manager provides quality focused customer… more
- Catalent (San Diego, CA)
- …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the ... PMP certification preferred. Experience in several operational functions, eg Manufacturing, Quality , Supply Chain, Technical Operations Toyota Production System… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The Quality ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of External Vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing ... perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol… more
- Merck & Co. (Rahway, NJ)
- …case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical ... Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team...Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of manufacturing … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …batch records, forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, ... treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor (2nd shift) as part of the Technical...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.… more
- Catalent (Harman, WV)
- Job Description: Manager , Supply Chain - WarehouseThe Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a ... on the way that the Harman's site operates. The Manager , Supply Chain - Warehouse will lead a shift...initiatives related to supply chain assets, workflow processes and operations . The ability to work efficiently and partner with… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and procedures and… more
- Aequor (Raleigh, NC)
- Remote Position - Flexible Hours Manager is open to seeing candidates with a minimum of 3&plus years of relevant working experience. Technical skills: advanced Excel ... (budgets), SharePoint, and Salesforce. Nice to have: clinical development process knowledge. Job Details: Manages one or more high-level, complex non-technical… more
