- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThis position will be part of the Compliance organization and will report directly to the Director, Compliance ... be responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning modules. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and participates in the strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensure all systems are operating well as designed. Ensures compliance with internal controls and accounting policies. Optimizes Financial Disbursement technology ... are consistently applied across the enterprise and manages governance to ensure compliance , understanding and remediate gaps.- Ensures compliance with State and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... Management, as necessary.Participates in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.Remain informed… 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)
- …considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate with other GxP quality representatives and ... Support continuous process improvement, interpretation of regulations, quality and compliance with regulations and company standards, policies and procedures through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable ... regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trends, and variances to ensure acceptable business practices, procedures and compliance have been followed.- Contract Management/ Finance Liaison/ Internal Audit ... service disruption is required.- Strategic Planning- Under the guidance of the Manager develop and implement business operational strategies that align with 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)
- …(SAP).Study execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical ... data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with vendors to define and manage service-level agreements (SLAs), ensuring compliance and high-quality service delivery- Monitor vendor performance, conduct regular ... training program for ME vendor teams, DSI ME team including onboarding, and compliance . Ensure training program aligns with ME objectives, best practices and DSI … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions, in regions and countries for all GOMA clinical activities. Process/Policies/ Compliance Provide input to process standards and tools to achieve excellence ... in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the development… 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 ... sessions - both live and virtualTrack speaker utilization and work with manager to escalate as needed.Coordinates Speaker Training and working closely with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure ... its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning, work in… 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 ... data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… 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
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory ... want to hear from you. Job Summary: As the Americas IT Security and Compliance Director, you play a pivotal role in ensuring the organization's adherence to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile… more
- Insmed Incorporated (Bridgewater, NJ)
- …purchase orders and inventory movements are managed, documented and administered in compliance with the company procedures and policies. The Planner must be ... the Drug Supply Chain Security Act (DSCSA) requirements.Implement and oversee compliance measures to ensure the traceability and security of pharmaceutical products… more
