- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …QA CMO Management and Global QA Audit Program teams.Responsible to ensure that quality improvement initiatives at Global External Suppliers are driven to ... of the end-to-end manufacturing process required.Must have solid understanding of quality management and continuous process improvement principles including… more
- Merck & Co. (Durham, NC)
- …patients around the world with our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support a new drug ... operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment, and qualification… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head ... risk areas/process improvement to stakeholders via the QMS scheme (ie, Quality Management Review, Quality Review Board) across the global CSPV organization… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... Are you ready to make a difference?The Position The Director , Medical Writing is an expert in medical writing...role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and will provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operational processes and implementing changes to enhance efficiency, productivity, and quality . Encouraging a culture of continuous improvement , promoting ... implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , PMO People & Process LeadGlobal Project and Alliance Management (GPAM) sits in the Research & Development organization at our ... informed decisions to manage their parts of the Research & Development division.The Associate Director , PMO People & Process Lead, is a unique role that will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight ... and continuously monitored for effectiveness, efficiencies, and areas of improvement .Responsibilities:Clinical Trial Operational Risk (CTOR) Management:Build and manage GCO… more
- Merck & Co. (Rahway, NJ)
- …Areas of expertise should include but not limited to--PP/PI, EHS, Production Execution, Quality and Logistics. This role also provides close support to the Process ... effort. Service Management: Manage the total scope of IT delivery (Cost, Quality and Time). Smooth transition of projects into production. -Managing expectations of… more
- Merck & Co. (Rahway, NJ)
- …Planning, Warehousing and Distribution and cross functional knowledge of Production Execution, Quality and- EHS. This role also provides close support to the Process ... effort. Service Management: Manage the total scope of IT delivery (Cost, Quality and Time). -Smooth transition of projects into production. -Managing expectations of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life Cycle ... and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... Governance Framework, related processes and develops metrics for continuous improvement opportunities; responsible for driving preliminary data processes related to… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of excellence to identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of success ... discussed with clinical development.Review, approve and/or drive related process related improvement to the diversity and patient voice space. This includes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cultivating a culture of Measurement Centricity within R&D to ensure continuous improvement in ways of working, leveraging both quantitative and qualitative means. ... Candidate will define Key Performance Indicators, Key Quality Indicators, Key Risk Indicators, and other targeted operational metrics in collaboration with R&D Line… more
- Eisai, Inc (Nutley, NJ)
- …relationship management.Provide leadership to managed services vendors to drive performance improvement , quality , and cost optimization.Drives a culture of ... we want to hear from you. Job Summary: As the Americas Infrastructure Director , your role involves collaborating with other Eisai regions and global Enterprise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with clinical and medical teams, CROs and other vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. ... optimize medical coding processes, technology, and standards. This position ensures quality delivery of medical coding for clinical trials, clinical development, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... is expected. The CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical Study Reports… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable cost. Identify/develop tools for efficient vendor management.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... The position holder will require strong skills in continuous improvement , project management, change management and risk management.Responsibilities Project level… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... to SAS and R. The position will require proven skills in continuous improvement , project management, change management, and risk management. The position will act as… more
