- Daiichi Sankyo, Inc. (Bernards, NJ)
- …procedures. Provide expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… 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 ... trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... Leadership Team members, and peers.Independently makes appropriate and compliant GMP decisions. Lead the establishment and improvement of QA practices to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development, analysis files development, data surveillance review, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as ... analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to… more
- Genmab (Plainsboro, NJ)
- …expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible ... contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for… more
- Genmab (Plainsboro, NJ)
- …integral part of the product roadmaps and planning and embed code validation services in POD processes.Security Awareness: Actively promotes information security and ... TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such as Leadership Team of IT&D, POD Managers,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Provide expertise and solutions to CSV questions and issues. **Responsibilities** - Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer ... diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Citigroup (New York, NY)
- The Senior Audit Manager is a senior level management position responsible for managing a complex and critical unit within Internal Audit, in coordination with the ... Responsibilities: . Manage a team of Internal Audit professionals, recruit staff, lead professional development, build effective teams and manage a budget . Ensure… more
- TD Bank (New York, NY)
- …for this role. **Line of Business:** Audit **Job Description:** The Audit Manager is accountable for overseeing the planning and execution for audits covering ... of audit documentation. Oversees findings follow up and issue validation . + Ensures audits are executed and completed in...matter areas + Adapt, promote and champion change + Lead and manage small to medium sized teams +… more
- TD Bank (New York, NY)
- …+ Generally leads a team focused on assigned audit and generally assumes the lead position on the audit, providing supervision and assignments to team members as ... status, and findings + Works at direction of Audit Manager + May perform testing procedures for more critical...in Charge on an Audit + May participate and/or lead assigned special projects + Provides feedback on staff… more
- Elevance Health (Morristown, NJ)
- **Diagnosis Related Group Clinical Validation Auditor-RN** **Location:** This position will work a hybrid model (remote and office). Ideal candidates will live ... of one of our PulsePoint locations. The **Diagnosis Related Group Clinical Validation Auditor** is responsible for auditing inpatient medical records to ensure… more
- Bristol Myers Squibb (Summit, NJ)
- …place than here at BMS with our Cell Therapy team. The **Senior Manager , Business Operations Lead ** is responsible for performance management and scheduling ... ensuring appropriate controls, complete traceability, and efficient operations. The Sr Manager schedules, plans, maintains KPIs and ensures SLA adherence for all… more
- TD Bank (New York, NY)
- …the Risk Assessment Methodology and processes. The FCRM US Risk Assessment ABAC Senior Manager will lead the execution of the ABAC risk assessments through ... bank in both 1LoD and 2LoD functions, and business lines. The Senior Manager , Financial Crime Risk Oversight oversees the team and leads 2nd-line oversight… more
- Bristol Myers Squibb (Warren, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Manager , QA Engineering (Analytical Lead )** **Location: Warren, NJ** This ... for first-in-human and pivotal clinical trials. **Key Responsibilities:** QA lead on quality control bioanalytical and microbiological related activities: +… more
- Bank of America (New York, NY)
- …model stakeholders and senior management with regard to communication of submission and validation outcomes Model Validation Lead ("MVL") oversees the team ... Quantitative Finance Manager Charlotte, North Carolina;Jersey City, New Jersey; New...of approval decisions on relevant model development or model validation tasks, critical feedback on technical documentation, and effective… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Manager for Global Technical Services (GTS) IT Systems plays a crucial ... Additionally, you will support the execution of Computer Systems Validation processes. **Desired Candidate Characteristics:** + Prior experience supporting… more
- Colgate-Palmolive (Piscataway, NJ)
- …your career a reason to smile and join our global team! We are looking for a Manager , Plant LIMS & Kneat to join our PLM team who will report to the Senior Director. ... What you will do + Lead efforts to implement LIMS and Kneat for Plant...on documentation required for FDA Part 11 Computer System Validation + Manage Digital Library platform, budget, vendor relationships,… more
- Actalent (Parsippany Troy Hills, NJ)
- Job Description Clinical Data Manager who will work collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions ... working with CROs performing data management tasks for assigned study. Coordinate, lead and perform clinical data management activities for assigned studies in… more
