- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … and compliance standpoint and establishes a comprehensive interface for risk and issue management with strategic development partners.Close partnership with ... (SMEs), and other functional area partners to ensure GCO risk management activities are executed and continuously...clinical quality management and other compliance functions within and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the GMP road map to meet changing regulatory and business needs.Lead remediation and risk management to assure the organization's Quality Management System ... collaborators, CMOs, and other key company partners to ensure a culture of compliance at all levels.Create and maintain project management methodologies. Support… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …evaluate and revise the CM plan as necessary.Identify areas of potential non- compliance and assist in the remediation of risk ,Responsible for the ... support the leader in the development and implementation of the Compliance Monitoring Program, specifically Federal healthcare laws, FDA promotional guidelines, and… 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 Clinical ... next steps for strategic process update and/or information sharing.Responsibilities:GCP Compliance :Develop seamless partnerships within GCO and non-GCO functions to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has moderate skills in continuous improvement, project management , change management , and risk management . Responsibilities Leadership, Direction, and ... and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionGlobal Trade Compliance (GTC) is primarily responsible to determine trade compliance requirements and processes, as well as executing select trade ... compliance functions that are best performed on a global...9817 prototype provision for US imports;Work with global trade management programs like SAP GTS and One Source to… 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). ... timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally ... role of both operational strategy and study execution. Responsibilities Study Management & Leadership: Has primary accountability for operational study level time,… more
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …colleagues to implement continuous improvement opportunities, review issues log, develop risk mitigations strategies and ensure all systems are operating well as ... designed. Ensures compliance with internal controls and accounting policies. Optimizes Financial...delivery and follow through execution.- Assist with the daily management of the customer support ticketing system for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …-Leads the review and analysis of site level activities through targeted risk -based site contacts and on-site visits to monitor study sites protocol execution ... and compliance to applicable DS SOPS and procedures -Enable ways for GPTs and Study Management Teams to have conscious inclusion trainings, and tools for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position will require proven skills in continuous improvement, project management , change management , and risk management . The position will act as main ... matter expert in meeting or teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description : Senior Specialist Facilities Management Provide facilities management and project support to IFM program, maintenance and ... are not limited to: Provide support for maintenance, IFM and project management to ensure compliant, reliable, and efficient operating performance Interface with… more
- Eisai, Inc (Nutley, NJ)
- …working closely with IT teams to ensure successful deployment and integration. Compliance Management :Assist in maintaining compliance with relevant ... the implementation of Security Scorecards globally and driving third-party risk management processes with other regions.Qualifications Bachelor's degree… more
- Merck & Co. (Rahway, NJ)
- …of a team of enthusiastic scientist and engineers supporting chemical management , chemical stewardship, hazard communication, environmental risk assessment and ... direction on future-driven initiatives related to Product Stewardship and compliance .Oversee the chemical management systems, hazard communication (Safety… 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)
- …for product concepts and solutions considering competitive factors, market demand, risk management , program economics, strategic fit, and operational ... a medical perspective on strategy and tactics that ensure compliance and alignment with standards of care.- The Veterinary...and key internal partners on the strategy, development, and management of KOLs and Advisory Board for our company's… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …complying with one or more regulatory programs: RCRA, Title V, Process Safety Management (PSM), Industrial Hygiene, BioSafety and High- Risk Work (eg elevated ... site. The EHS team at Rahway supports research laboratories, clinical manufacturing, facility management and office areas for global teams as part of the Corporate… more
