- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... and adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program… 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 ... checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates… 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 ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs),… more
- Merck & Co. (Rahway, NJ)
- … for assigned protocols and sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and ... and externally. Acts as primary site contact and site manager throughout all phases of a clinical ...of site relationships through all phases of the trial.Performs clinical study site management/monitoring activities in compliance … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and quality tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This position reports to the Director, Case… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific… more
- Novo Nordisk Inc. (San Antonio, TX)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… 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 ... Technical Operations team based in Raritan, NJ. Role Overview This...responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight...with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to… more
- Catalent (San Diego, CA)
- …, Quality AssurancePosition 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 Safety, Quality performance, Operational… 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
- Merck & Co. (North Wales, PA)
- …of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy. A portion of the ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP 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
- 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 ... role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements. Collaborate with… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager of Supply Chain and Logistics plays a crucial role in supporting ... both the commercial and clinical supply chains at Insmed. The primary focus is...management practices, as well as implementing and monitoring DSCSA compliance initiatives. This is a non-supervisory position This role… more
- Aequor (Raleigh, NC)
- …ensure appropriate budgeting process. Ensuring adherence to corporate training and compliance requirements for the function. Providing staff operations support ... Remote Position - Flexible Hours Manager is open to seeing candidates with a...advanced Excel (budgets), SharePoint, and Salesforce. Nice to have: clinical development process knowledge. Job Details: Manages one or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... area including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director… more
- Catalent (Manassas, VA)
- …help create engaging new products consumers will love.The Site Procurement Manager is responsible for procurement leadership, sourcing and procuring materials, ... services, and capital for the site. The Site Procurement Manager will lead site procurement team and initiate and foster relationships with site stakeholders,… more
