- Daiichi Sankyo, Inc. (New York, NY)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product(s), and their approved indications,...as per SOP 805.21,'Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).' Qualifications: Successful candidates will be able… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and sustainability ... of the Global Clinical Data Standards for quality submissions and success of the Daiichi Sankyo R&D...also some of the requirements of this role. The Manager , Clinical Data Standards should be a subject matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Bio Sample Operations is responsible for supporting the oversight of the ... (SOIs) to support biosample management activities. Ensure appropriate performance and quality targets are established (via metrics and KPIs) for biosample related… 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)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...collection of diverse external data types. Advises Study Data Manager on complex vendor management issues and provides guidance… 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
- Eisai, Inc (Nutley, NJ)
- …& Architecture, s/he is the Global IT department's trusted leader and manager who assesses and provides objective risk assessments and guidance regarding Eisai's ... degree in Technology or Business highly desirableCertified Information System Manager (CISM) certification is essential. Additional Certified Information Systems… 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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …are excited to introduce a new opportunity for an experienced Program Manager to lead enterprise-wide data and technology programs for our Animal Health ... talented teams of motivated tech professionals who are committed to rapid, high- quality delivery. We are passionate about creating a culture where diversity and… more
- Merck & Co. (Rahway, NJ)
- …audio production (microphone, teleconference, multi-language feeds, etc.), floor manager , encoding support, and any additional production requirements based ... abstract concepts into effective deliverablesMust be detail-oriented and able to apply quality control practices to all projectsStrong interest in video and audio… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing...of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and… more
- Aequor (Parsippany, NJ)
- …Medicaid systems and authorize transactions. Document errors and perform research.Conduct initial quality check on summary data on all claim submissions to ensure ... Complete Medicaid analyzes and documentation on assigned states/programs. Communicate to manager for key findings and changes to state programs.10% Provide backup… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... internal programming colleagues in completing the deliverables with high quality according to timelines, and provide recommendations to improve process.Compliant… more
- Merck & Co. (Rahway, NJ)
- …and analyzing system and passive data governance reports to ensure high quality data and timely and complete synchronization between systems. Acts to resolve ... preparation and overall accounting knowledge. Thorough understanding of data manager packages. Strong understanding of Enterprise Process Management to troubleshoot… more
