- 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
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. ... . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply...analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works… more
- Merck & Co. (Rahway, NJ)
- …to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. ... our depot network and further through to distribution and management of materials to the clinical site.... Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related… more
- Merck & Co. (Rahway, NJ)
- …to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply... Skills: strong knowledge of the principles of project management and clinical customer relationship management… 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
- Merck & Co. (Rahway, NJ)
- …formulation and process development through process tech transfer, scale-up activities, quality investigations, change management , and authoring GMP standard ... operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and… 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
