- Merck & Co. (Rahway, NJ)
- …and mentoring of engineers within the group. Provide engineering and quality engineering (QE) support, ensuring facilities, utilities and equipment are maintained ... engineering drawings, equipment database tracking, and Key Performance Indicator (KPI) data . Lead, facilitate and/or participate in investigations, and any related… more
- Merck & Co. (Rahway, NJ)
- …prioritize multiple projects and activities across multiple sites. - 3 years' experience in Data Management and Data Governance - - Preferred Experience and ... Job Description Position Description: Associate Director , Automation Th is position will primarily be...for ensuring reliability and efficiency of site operations through data analytics .- This role will assess current state… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …Template asset, delivering enterprise-level capabilities through harmonized business processes and data .-The team is responsible for the operation of all our ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary Sr. Director Data Management contributes to the vision, direction and ... strategy for Data Management globally and executes the strategy...etc.)Able to lead program and initiative teams to achieve high- quality , on-time deliverablesEffective management and development of… more
- Eisai, Inc (Nutley, NJ)
- …enhancements, and maintenance. Aligns an organization's IT platforms with business processes/ data to improve the efficiency and productivity of business operations ... information systems components (ie, end users, business processes, applications, data , IT platform hardware/software, and networks). Essential Functions Strategy and… more
- Tris Pharma (Monmouth Junction, NJ)
- …guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves as Deputy to ... Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement clinical ... CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data...collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Companion Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and Clinical Development. Responsibilities Designs and ... requisition forms, scoring forms, and DTS documentsDevelops and implements a testing quality monitoring program, ensures consistent data monitoring and output… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the following areas/ SAP Finance modules: Asset Management , General Ledger, Travel Management , Master Data , Procure to Pay, Invoice to Pay, Project Systems, ... Material Management , Production Planning, Logistics, Sample Allocation Management Functionality, Master Data , Reporting, Integration/Interface monitoring and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director of Regulatory Writing is a key role responsible for producing ... scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST and DSE to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... updated Core Data Sheets, EU and US Documentation: As the project...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …administration of validated electronic systems such as LMS or other quality management systems.- Must possess strong interpersonal, communication, negotiation ... for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building and management review.-...periodic alerts to teams to ensure that shared point data is current and accurate- In collaboration with Head,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with… more
