- Eisai, Inc (Nutley, NJ)
- …relevant security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution ... review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of… 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...site mission, vision, and goals through efficient and safe operation of equipment and compliance with Good… 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
- 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)- ... for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, company policies and procedures… more
- Merck & Co. (Rahway, NJ)
- …performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, ... 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)
- …groups in alignment with the sales management team and commercial operations groups.--Additionally, this position will stay abreast of the external environment ... and execute the defined processUse financial tools and ensure compliance /performance to the agreements (hold customers accountable to their...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provide input to process standards and tools to achieve excellence in trial operations and management.Monitor and ensure compliance and highest quality standards ... diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global… 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 ... with vendors to define and manage service-level agreements (SLAs), ensuring compliance and high-quality service delivery- Monitor vendor performance, conduct regular… 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)
- …cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The primary responsibilities of the Manager , Omnichannel Marketing is to support the development, planning and implementation ... customer segments across the portfolio in partnership with brand teams. The Manager should assess external digital opportunities and threats, customer journeys, and… 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 ... as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the established RD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global Quality departments… 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
- 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 ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, ... of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,-Sponsor SOPs, Local Laws & Regulations, Protocol, Site… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and others as needed to communicate with field sales.Identify and action any policy or compliance risks and escalate to manager as neededPartner with Legal and ... training materials and content on the speaker engagement platform.ResponsibilitiesProgram Operations :Lead the coordination of speaker bureau nomination process with… more
- Merck & Co. (Rahway, NJ)
- …with other tools, technologies, security controls, governance processes, and compliance validation.Develop a library of deployable and documented design patterns ... align with SRE principles for reliability, scalability, and efficient operation .Establish strong working relationships with business and technology leaders to… more
- Merck & Co. (Rahway, NJ)
- …these capabilities and we minimize our risk of outages that can impact our operations .The engineer will also work with the Print Product Manager to adopt ... our IT and business goals. The engineer will also work with the product manager to establish our incident and support framework.The nature of the position requires… more
- NJ Transit (Newark, NJ)
- Manager , Compliance Operation Civil Rights & Diversity Job Description: Move forward with us! At NJ TRANSIT, you'll join us in transforming the third-largest ... Summary This role performs critical DBE certifications, and DBE and SBE/DVOB contractor compliance operations functions on behalf of the Office of Business… more
