- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work in a growing Clinical Operations ... Oversee performance of CROs, third party vendors, and contractors, including co- monitoring , to ensure compliance with study protocol, and identifying areas of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... by consulting with executional teams to drive optimal performance Performance Monitoring : Report on key marketing performance indicators (KPIs) to measure the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A WEEK, IN OFFICE IS REQUIRED The Position The purpose of the Content Project Manager role is to oversee and manage the execution of content projects from strategy ... leveraging project management tools such as Workfront, the Content Project Manager monitors task progress, mitigates risks, and maintains efficient workflows. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP CX Manager -CV/Renal will be a critical driver in ensuring the successful execution of brand/therapy ... by consulting with executional teams to drive optimal performance Performance Monitoring : Report on key marketing performance indicators (KPIs) to measure the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and ... on a global level for Change Management process. Maintaining, adapting and monitoring a comprehensive change management process for IT systems and services.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the R&D Oncology and Specialty Medicine strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters ... Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs) by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production...required, run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for study committees (eg, Executive Committee). Provides input to Clinical Operations on monitoring plan (eg data fields to be SDV'd) and to Biostatistics on ... Statistical Analysis Plan (SAP).Study execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon ... approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …quality system interface for Siemens Building Management System (BMS) and Environmental Monitoring System (EMS). Relationships Reports to: Manager of Automation ... regulatory inspections of BMS and relevant projects as needed Work with the project manager to coordinate the activities and needs of the installation team Work with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to ... process/aseptic observations, critical site review, critical alarm management, environmental monitoring incursion/excursion response.Will support and prepare Set-up Activities for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to/from Data Monitoring Committees (DMCs) Acts as substitute for the Manager For content related matters, eg document reviews, approvals and signatures (PSUR, ... Is responsible for Safety Input to all activities for Risk Based Monitoring across the development project Physical Requirements Approximately 10% overnight travel… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk Assessment Categorization Tool (RACT) Ensure country ... Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy...least 5 years of experience as a Clinical Trial Manager Experience with global clinical trial operations, in multiple… more
- Merck & Co. (Durham, NC)
- …microbiological testing; evaluation of environmental microbiological samplesConducts environmental monitoring sampling to include active air and surface sampling ... alignment with department objectivesConducting In-Process and Release testingConducting Environmental Monitoring of processes and on a routine basisProblem SolvingIdentifies… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The QC Microbiology Supervisor leads, and monitoring the daily operations, activities, and workflow for the laboratory personnel. Additionally, you will implement ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… more
- Merck & Co. (Durham, NC)
- …and approve Performance Qualification documents pertaining to environmental monitoring and process qualification.Provides Quality input, direction, and approval ... ability to meet performance objectives.Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with… more
- Merck & Co. (Durham, NC)
- …to meet performance objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review and review of ... environmental monitoring data. Perform review of process simulation batch records. Perform Quality retain sample management activities, if applicable. Lead Shopfloor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... program, including legal review and support for policies, training, monitoring , and auditing projects. Ensures adherence to pharmaceutical industry regulations.… more
