- 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 ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
- 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 ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- 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 ... quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference list… more
- Merck & Co. (North Wales, PA)
- …the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead,...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (North Wales, PA)
- …Clinical Trial Team (CTT)May work closely with the Medical Writer on clinical /scientific and regulatory documents and the Study Manager on study ... Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries...your employment may pose an undue burden to business operations , in which case you may not be offered… 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
- 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
- Merck & Co. (OH)
- Job DescriptionThe Oncology Key Account Manager is the primary Oncology point of contact for our Company with large Oncology group practices and integrated delivery ... becoming a trusted resource in demonstrating value.- - The Oncology Key Account Manager will be responsible for calling on large Oncology Group practices and… 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)
- …MSA discussions of External Vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing ... opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of… 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)
- …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)
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Aequor (Thousand Oaks, CA)
- …Let's do this. Let's change the world. is seeking an Organizational Effectiveness Manager External Worker to join our Research team. In this vital role you ... work remotely. Key responsibilities may include the following strategic planning & operations activities: Provide operational support to Chief of Staff of Research… 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 ... preferred A minimum of eight (8) years of progressively responsible clinical development/trial experience within a pharmaceutical, biotechnology, or CRO required.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the ... areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process… more
