- Eisai, Inc (Nutley, NJ)
- …assessment.Collaborates with global stakeholders from EIT and leaders across regions in Compliance , Ethics, Risk Management , Legal, Data Privacy, and ... controls.Monitor IT compliance risks to an acceptable level.Manage IT compliance issue resolution.Report compliance risk levels to key… more
- Merck & Co. (Rahway, NJ)
- …and various Divisions and functional areas to execute a robust Enterprise Risk Management programWorks with Relationship Managers from across the enterprise ... Third Party Risk questions during auditsEnsures appropriate escalation of risk management gaps, issues, and concerns to managementManages activities related… more
- Merck & Co. (Rahway, NJ)
- …Advanced skills in strategic thinking, project management , ability to lead during ambiguity, analysis and risk -based decision-making and stakeholder ... (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead establishes and/or - local clinical Quality Management System (CCQMs)… more
- Eisai, Inc (Nutley, NJ)
- …implementing and maintaining robust cybersecurity practices, including risk management , access controls, network security, and compliance , is ... Security, and provide leadership to managed services vendors. Organizational management responsibilities include resource prioritization, alignment with the CIO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities:Clinical Trial Operational Risk Management :Own, lead and manage GCO ... and compliance standpoint and establishes a comprehensive interface for risk and issue management with strategic development partners.As needed, involved in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … management sciences, and risk management tools and resources.- Risk Management Compliance Inspection Readiness Champion. Serve as member of ... management aware of any gaps in risk management planning, creation, and execution- Lead /Manage RMP initiatives. Lead and/manage RMP initiatives and… more
- Merck & Co. (Rahway, NJ)
- … equipment development and maintenance activities -and support facility operations, compliance investigations/change management in any of our enabling ... and/or qualification.Experience providing technical mentorship.Experience in leading and supporting compliance investigations and change management .Familiarity with US… more
- Merck & Co. (Rahway, NJ)
- …state business objectives. Within the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all areas of SAP Technology.-They ... Middleware/Integration and Reporting/Analytics standards, patterns, and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology… 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 ... next steps for strategic process update and/or information sharing.Responsibilities:GCP Compliance :Develop seamless partnerships within GCO and non-GCO functions to… more
- Merck & Co. (Rahway, NJ)
- …to lead and support facility operations, process development activities, compliance investigations/change management , authoring of GMP documentation, and ... in a fast-paced job that provides a high degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot… more
- Merck & Co. (Rahway, NJ)
- …Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements- Serving as regulatory labeling point ... to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions… more
- Merck & Co. (Rahway, NJ)
- …responsible to support the operational functions of the Third Party Quality Management group, which provides quality oversight of suppliers and GMP service providers ... profiled and platform vendor base,Operational execution for phase appropriate, risk based processes for third parties' performance oversight and monitoring,Support… 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). ... expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management , will be accountable for the authoring and lifecycle management ... GCP standards. The Associate Director will also be responsible for the creation, management , and documentation of GCO's CRO SOP review and maintaining the master… more
- Merck & Co. (Rahway, NJ)
- …along with the global teams to develop options and alternative solutions.Category management ensuring compliance to the procurement process and supporting the ... design and implementation of sourcing strategies for the energy/renewable energy category. Lead project execution and drive sourcing activities (RFI, RFP, e-sourcing,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other Leadership Team members to optimize processes, resource allocation, and risk management strategies leveraging project management tool ... Head of Centre for RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead ...and track the hiring timeline according to plan, identify risk or gap for timely escalation and develop contingency… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and along the GvP modules in support of a proactive quality risk management process.Interact with the audit and compliance function for the development of ... in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness, compliance , and inspection preparedness for… more
- Merck & Co. (Rahway, NJ)
- …the CTC, CRAs and-COM).-Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF and other ... This role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with International… more
- Merck & Co. (Rahway, NJ)
- …of performance in a dynamic environment, leaning into areas of talent management and succession planning, operational efficiency and compliance , and external ... the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating… more
- Merck & Co. (Rahway, NJ)
- …operations, process development activities, support compliance investigations/change management , author GMP documentation and manage/ lead engineers in ... molecule drug substance and/or biologics process development.Experience in supporting compliance investigations and change management .Familiarity with US and… more
