- Eisai, Inc (Nutley, NJ)
- …support and rollout of relevant technologies and platforms. Accountable for overall quality and delivery of HCM based technology solutions. Application Support and ... root cause of issues creating the best solution for Eisai considering quality , cost, and speed requirements. Excellent written and verbal communication skills and… more
- Eisai, Inc (Nutley, NJ)
- …and rollout of relevant technologies and platforms. Accountable for overall quality and delivery of Revenue Management (Contracting, Medicaid, Govt. Pricing, ... root cause of issues creating the best solution for Eisai considering quality , cost, and speed requirements. Excellent written and verbal communication skills and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology ... Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... programmer.Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product… more
- Merck & Co. (Rahway, NJ)
- …to support achievement of immediate and future state business objectives.The Cloud Project Manager will play a critical role in driving releases within our global ... well as leading the planning, coordination, and execution. The Cloud Project Manager will ensure adherence to all required change management processes. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Manager , ERP Applications is accountable for maintaining and modifying assigned ERP ... elements of each enhancement or project.Responsibilities:Responsible for developing high quality solutions based on Functional Design documents. Perform system… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ... ensure the adherence to the Quality Manual. Responsible to ensure efficiency, accuracy and standardization...ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …setting, to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead on generation of study ... and co-authoring primary and secondary sections of regulatory documents. The Manager , Clinical Pharmacology is expected to identify, generate and execute study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the oversight of the ... Instructions (SOIs) to support biosample management activitiesEnsure appropriate performance and quality targets are established (via metrics and KPIs) for biosample… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful ... 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. (Bernards, NJ)
- …strategy by spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process and procedures. ... (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development and management of other ad hoc special projects as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review ... policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor performance, assessing spend, maximize value from vendors, ensure service quality . Reduce costs without compromising quality . Monitor projects and ... seek efficiency. Mitigate potential risks, including any third-party disruptions.- Evaluate current vendor processes and systems for continue to enhance programs. - Legal and Compliance Management- Manage and oversee complex processes for approval of material… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ensures all systems and data operate and are maintained to the agreed quality and service requirements- Leads the planning and deployment of system upgrades, ... including the scheduling of key activities and communicating of system downtime to appropriate parties. Identify opportunities for automation and reduction of manual processes across the team in conjunction with our Financial Disbursements roadmap.- Leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of validated electronic systems such as LMS or other quality management systems.- Strong interpersonal, communication, negotiation and problem-solving skills.- ... Organizational awareness (eg inter-relationships of departments, business priorities), including experience working cross-functionally, Cross cultural and in global teams.- In depth knowledge and working experience with common computer software programs, ie MS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.Procedure Development: Supports the process ... redesign activities to ensure compliance and consistency across clinical study start-up activities. Reviews and provides input to SOPs, SOIs, and process guides.Qualifications: Successful candidates will be able to meet the qualifications below with or without… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input ... to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor… more
