- Eisai, Inc (Nutley, NJ)
- …security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the ... vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training , and track KPIs.Define critical processes and manage recovery… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the ... 24-hour operations team for the site.- The Manager will direct a team of hourly personnel who are accountable for the 24-hour operations of the site.- The … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are ... in database and research tools.ResponsibilitiesSupport the Head Global QA strategy and operations (RDPVMA QA)on projects needing to be coordinated with both DSI QA… more
- Merck & Co. (Rahway, NJ)
- …internally and externally.Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and ... Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned… more
- Merck & Co. (Rahway, NJ)
- …of low or non-performance.The role will work across the different country operations roles (eg CRM(Clinical Research Manager ), CRA(Clinical Research Associate)- ... individual is responsible to-manage/oversee a team of CTCs(Clinical Trial Coordinator).As line manager the role is critical to continuously develop future talent by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …maintaining innovative technology solutions for Meetings and Events, ensure smooth operations , and collaborating with vendors to optimize services and achieve ... successful outcomes. The role will oversee M&E vendor training programs and initiatives. The role will be crucial to enhancing participant experiences, streamlining… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations . Experience in training , process improvement, and project management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL ... and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …methodology in accordance with current regulatory guidelines.- Provide appropriate training and guidance on global DX computer system validation procedures ... and qualification and Computer Software Assurance (CSA), SDLC related to pharmaceutical operations . required- 1 or More Years Direct dealings with FDA, EMA, PMRA,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... existing systems in Regulatory AffairsRequired Skills5 years of Regulatory Operations experienceExtensive knowledge and experience with Microsoft Office, Adobe… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations ... based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership… more
- Merck & Co. (Rahway, NJ)
- …a roadmap of prioritized improvements to our infrastructure (eg knowledge management, training , and enabling systems) and drive initiatives on that roadmap that ... include: Key Responsibilities PMO owner and steward of "Development Project Manager " user persona; accountable for defining business process user stories and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project. As a project ... manager this position is accountable for partnering with the...Team and Global Clinical leader to ensure effective team operations through meeting management, development plan/timeline management, scope management,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … sessions - both live and virtualTrack speaker utilization and work with manager to escalate as needed.Coordinates Speaker Training and working closely with ... programs. Responsible for maintaining speaker profiles, creating and delivering training materials and content on the speaker engagement platform.ResponsibilitiesProgram… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …external vendors by engaging with key cross-functional stakeholders (Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) for establishing data ... vendor selections and work alongside DS Procurement and DM operations to qualify preferred data vendors to ensure DSI...data management subject matter expert and provides guidance and/or training to study teams in preparation for upcoming audits.… more
- Merck & Co. (Rahway, NJ)
- …and maintain documentation for SAP Basis processes and procedures.Provide training and knowledge transfer to junior team members.Collaboration:Collaborate with other ... S/4, SAP BTP, Fiori, HANA, SLT, and SAP Solution Manager .Strong database administration skills (SAP HANA, Oracle).Knowledge of new...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Insmed Incorporated (Bridgewater, NJ)
- …proven management and/or leadership experience in an R&D, manufacturing/ operations or commercial context in a biotech/bio-pharmaceutical environment required.Project ... and a positive, can-do attitude.Must be an experienced pharmaceutical/biotechnology program/project manager with experience in leading drugs through all phases of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. Key Responsibilities Perform peer ... but not limited to eLIMS Electronic Notebooks, laboratory formbooks, training formbooks, instrument logbooks, and records. Utilization of electronic systems… more
