- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis ... governance bodies.Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence to internal… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Merck & Co. (Rahway, NJ)
- …and inclusion so everyone can bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's ... and robustness across organizational deliverables.- In this role, the DSCS Digital Program Manager will provide strategic and tactical direction and partner… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... define priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with publishing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The Quality ... within quality systems processes. Key Responsibilities Lead the CAPA program for the CAR-T manufacturing site. Oversee metrics, trending, and reporting of… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The ... Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned… more
- Merck & Co. (Rahway, NJ)
- …mentoring to the CTCs, as well as for interns-delegated to the Clinical Operations team based on the Internship program , while-properly managing situations of ... low or non-performance.The role will work across the different country operations roles (eg CRM(Clinical Research Manager ), CRA(Clinical Research Associate)-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS)… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …maintaining innovative technology solutions for Meetings and Events, ensure smooth operations , and collaborating with vendors to optimize services and achieve ... define and manage service-level agreements (SLAs), ensuring compliance and high- quality service delivery- Monitor vendor performance, conduct regular evaluations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Enrichment services, including data standardization, natural language processing o Data Quality operations that standardize data definitions, implements ... as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the… more
- Aequor (Raleigh, NC)
- Remote Position - Flexible Hours Manager is open to seeing candidates with a minimum of 3&plus years of relevant working experience. Technical skills: advanced Excel ... more high-level, complex non-technical projects within the constraints of scope, quality , time, and cost, to deliver specified requirements, including: Developing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …problems, and accuracy and precision requirements primarily focused o pharmaceutical operations and support equipment Develop, test, and validate, automated and ... in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports of all calibration and maintenance… more
- Eisai, Inc (Nutley, NJ)
- …unlawful actions.Oversee system data retention standards and verify system operations .Manage Eisai's information governance program , including JSOX ... security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Merck & Co. (Baton Rouge, LA)
- …actions implemented: volume and quality .Preventive actions implemented on time. Quality of communication with the manager , staff, and external ... team leader and/or the molding/marking adjusters and/or the Maintenance Manager on tools during production.Analyses, repairs, or replaces defective… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project. As a project ... manager this position is accountable for partnering with the...Team and Global Clinical leader to ensure effective team operations through meeting management, development plan/timeline management, scope management,… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
