- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will ... and trending to shape the future of Daiichi Sankyo clinical trials.Responsibilities- Process Improvement, Innovation and Optimization (IO):-Project manage GCO… more
- Merck & Co. (Rahway, NJ)
- …end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing ... making your impact today.- - Overview:- - - Global Clinical Trail Operations (GCTO) is a global organization with...operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project - - You… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting ... in accordance with DS standards. Act as the project manager of the clinical study team to...TLG before and after database lock.Ensure DS internal tracking systems are updated (eg Global Project Management System, GPMS).… more
- Merck & Co. (Rahway, NJ)
- …on-the-job training and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ProjectYou will ... join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global organization with...partner with CSSM team members to train on systems and tools to complete tasks and deliverables critical… more
- Novo Nordisk Inc. (WA)
- 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
- Merck & Co. (Rahway, NJ)
- …on-the-job training and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ProjectYou will ... join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global organization with...partner with CSSM team members to train on systems and tools to complete tasks and deliverables critical… more
- Merck & Co. (Rahway, NJ)
- …(PMO) which is responsible for the development, sustainment, and training of GPAM-owned systems , tools, and business processes as well as alignment with Finance, IT, ... and tactical input from diverse disciplines (eg, biology, chemistry, pharmacology, clinical , regulatory, access, supply, and other areas), as applicable to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility ... if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.Identify opportunities to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control, Client interface, Lab… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …face of complexity or disagreement Utilizes and enhances procurement and sourcing systems and tools: Follows up on system usage and proactively ensures compliance ... with the Novo Nordisk Corporate Procurement to promote optimal use of procurement systems and ensure NNIs involvement in global sourcing projects and related efforts… 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. ... Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, ... Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as applicable. Support MA/PV health authority inspections with adequate systems and process support, including facilitation of respective regulatory inspection ... inspection/audit CAPAs). Support MA/PV health authority inspections with adequate systems and process support, including facilitation of respective regulatory… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory and ... characterization for drug substance, drug product and reference standards. The Manager must possess a good understanding of pharmaceutical development processes from… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality rules and… 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 ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, ... they relate to Company-wide trainings and external/global trainings, as appropriate.Maintain systems and document training curricula to ensure that only current… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the pharmaceutical industry. Optimize and tune data infrastructure and systems for performance, reliability, and scalability.Qualifications: Successful candidates will… more
