- Merck & Co. (Rahway, NJ)
- …planning and execution of one or more clinical trials. You will assist the Lead Clinical Scientist and study team with the scientific conduct of clinical ... join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global...training and operational project assignments under the direction of Lead Clinical Scientist and Lead … more
- Merck & Co. (Rahway, NJ)
- …and innovative solutions that enable new SAP capabilities and technologies. As the Clinical Manufacturing Delivery Lead for our Research & Development Division , ... you will be responsible for delivering SAP solutions to our Global Clinical Manufacturing user community. You will p articipate in interviews with our company's'… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to support ... experience in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance. required Experience Qualifications4 or More… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... service providers and working with internal departments to progress clinical supply projects. Every effort has been made to...the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical ... Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader...in one or several programs.- Partner and collaborate with Clinical Operations , Biostatistics and Data Management, Regulatory… more
- Merck & Co. (Rahway, NJ)
- …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans ... Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including ... site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations... quality metrics and share with study team, Operations Program Lead , and Sr. Director for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path ... site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations... quality metrics and share with study team, Operations Program Lead , and Sr. Director for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in ... adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. ... of 7 years of experience required Experience Qualifications.7 or More Years 7 years clinical operations experience in trial diversity and patient access and/or … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight ... for risk and issue management with strategic development partners.Close partnership with clinical quality management and other compliance functions within and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will ... in due diligence activities during the vendor selection process.Close partnership with clinical quality management, SVO and other compliance functions within and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical ... veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will… more
- Merck & Co. (Rahway, NJ)
- …lockout/tagout and hazardous energy control procedures.- Support mechanical aspects of clinical operations , including support/initiation and gatekeeping of work ... Program requirements. Work collaboratively with various partner groups such as operations , equipment vendors, site maintenance, quality .Provide quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical ... Program Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites...our CMO's and internal packaging sites for GMP processing operations . This position will work with a label translation… more
- Eisai, Inc (Nutley, NJ)
- …security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… more
- Merck & Co. (Rahway, NJ)
- …work that includes direct project support of the current our Company's clinical pipeline and prospective technology development that enhances our ability to deliver ... for working closely with their counterparts across Development Sciences and Clinical Supply (DSCS), Discovery, Preclinical and Translational Medicine (DPTM), and our… more
- Merck & Co. (Rahway, NJ)
- …The Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at the ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
