- Merck & Co. (Rahway, NJ)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Senior Director will manage the entire cycle of clinical development, including study design, initiation, execution,- monitoring, analysis, regulatory reporting,… more
- Merck & Co. (North Wales, PA)
- …in collaboration with Data Management /Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of ... writing, and presentation skillsEducation/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management , and/or medical… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and ... compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or … more
- 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 ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...within the organization and function within the role of Quality Business Partner where requested by management … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experienced quality representatives and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills: Clinical Site Management , Clinical ... Job Description Responsibilities :This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early… more
- Merck & Co. (Rahway, NJ)
- …action (CAPA).- Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & ... Process Engineering, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Management System, Quality Management , Quality … more
- Eisai, Inc (Nutley, NJ)
- …vision and hands-on operational management strategies to expedite clinical operations activities.Ensure the timely, quality , and successful execution ... to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role... development programs across different phases.The VP of Global Clinical Operations is responsible for the management ,… more
- Genmab (NJ)
- …of our Global Medical Writing team, you will drive the development of high- quality clinical documents to support operational, medical, and regulatory activities ... immunology experience preferredDemonstrated experience authoring protocols, investigator's brochures, and clinical study reports. Senior level candidates should… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews...ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the ... to determine risk factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management , Statistics). This position requires skills… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management , regulatory agencies, or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment Effective in fast-paced environments with a focus on quality and documentation Skilled in change management and guiding teams ... cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity… more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards ... : This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Merck & Co. (Rahway, NJ)
- …manufacturing. -The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design ... technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages scientific/technical experience to develop… more
- Formation Bio (New York, NY)
- …efforts to ingest and transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment.Effective in fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams ... Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues, to deliver… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence clinical and ... administration including inhalation, implantation, and injection.--This position serves as a senior individual contributor who will be responsible for applying deep… more
- Merck & Co. (Rahway, NJ)
- …human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... to convert complex ideas and information into simple readable formSolid project management skillsFamiliarity with clinical data management conceptsStrategic… more
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