- Novo Nordisk Inc. (Plainsboro, NJ)
- … and NAO Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and scientific meetings, as necessary ... team members. Relationship Reports to head of North America Operations Quality Pharmacovigilance Oversight . Maintains positive rapport and working relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality ... (PV) oversight . This role fulfills the PV Oversight function in PV quality control processes,...Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management . This role fulfills the PV ... Oversight function in PV deviation management processes, as well as providing SME-level input from...ie team members. Relationships Reports to head of NAO Quality PV Oversight . Maintains positive rapport and… more
- Merck & Co. (Rahway, NJ)
- …global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and ... quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …bachelor's degree required with a minimum of 8 years of experience in data management and reporting; advanced degree preferred Proficiency in relational ... support and communication channels related to the NovoCare® Patient Support Programs. Management of relevant data sets include compliance and database… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that ... against service level and KPIs.Manage the development of governance, business continuity, quality , and vendor monitoring plans. Maintain oversight for capability… more
- Eisai, Inc (Nutley, NJ)
- … Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible ... preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years...carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk factors with and for other technical departments (eg, Clinical, Medical, Safety, Data Management , Statistics). This position requires skills in working in a ... Oversight : Manages higher-level negotiation with external vendors. Provides oversight of quality /performance and budget, resources and timelines across… more
- Merck & Co. (Rahway, NJ)
- …Engineering, Building Automation Systems, Buildings Management , Business Decisions, Change Management , Contractor Oversight , Data Analytics, Data ... self-sufficiency.3 years of experience leading multiple large-scale automation initiatives, including data management and data governance.Ability to work… more
- Merck & Co. (Durham, NC)
- …First Time" mindset. Consistently deliver On-Time and In-Full - with First Pass Quality . Oversight and presence on the production floor at External Partner ... Partner).-- Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management ,… more
- Merck & Co. (San Francisco, CA)
- …in partnership with workstream and subteam leads, helps maintain resource planning data and escalates resource needs and changes.Implementation Oversight : helps ... Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware,… more
- Merck & Co. (North Wales, PA)
- …Travel Requirements: Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills: Data Management , Data Science, ... and study design, analysis strategy, and analysis results with highest quality . This individual is responsible for hiring appropriate, qualified staff, coaching… more
- Eisai, Inc (Nutley, NJ)
- …of innovative strategies.Experience in managing and directing related functions such as data management , CRO vendor management , procurement, and ... VP of Global Clinical Operations is responsible for the management , oversight , and direction of the clinical...of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This individual… more
- Merck & Co. (Durham, NC)
- …Durham sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At ... program for calibration technicians.Works as a liaison between Maintenance, Deviation Management , Quality and other Site Business Partners.Initiate, Review or… more
- Merck & Co. (Durham, NC)
- …Durham sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects ... customer needs to identify solutions.Works as a liaison between Maintenance, Deviation Management , Quality and other Site Business Partners.Initiate, Review or… more
- Merck & Co. (Durham, NC)
- …Durham sites.- This includes Energy Center, Vaccines Manufacturing and Bulk Facilities, Quality Labs, and Maintenance and Material Storage Facility (MMSF). At times, ... This support position will focus on planning maintenance execution, SAP Data stewardship and assisting with successful shutdown planning and implementation with… more
- Genmab (NJ)
- …ethics committees, answers to in-house questions related to data quality , safety monitoring, medical questions etc.Performs sponsor oversight of programming ... standards of data and produces well-structured, high quality data summaries in tables, figures and...study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety, Medical, Clinical… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director ... sets strategic directions and project priorities, providing scientific leadership and oversight and managing individual performance and cost center budgets. The… more
- Formation Bio (New York, NY)
- …timelines, budgets, and resources across biologics programs; ensure delivery of high- quality milestones on schedule. Technical Oversight Provide scientific and ... in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and execute… more
- Ascension Health (Austin, TX)
- …+ Experience with data governance concepts, data quality management or principles for information risk oversight + Experience in Master Data ... Deep knowledge of SQL, REDCap, Google Workspace, Tableau, Informatica Data Quality + Proven expertise in ...project deliverables + Consistently provide work effort estimates to management to assist in setting priorities + Deliver timely… more
