- Eisai, Inc (Nutley, NJ)
- …/study conceptualization, development of analysis plans, programming of core economic models, model calibration, model validation , interpretation of model ... results and sensitivity analyses, protocol, technical report and manuscript writing.Leads interactions with academic institutions and vendors, develops and maintains client relationships.As project lead/principal investigator has project budget, deliverable… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the SDTM deliverables for analysis and ... vaccine clinical development projects. Accountability predominantly includes creation and validation of Case Report Tabulation study data deliverables using… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver ... implementation teams (including external vendors) in the design, development, implementation, validation , roll-out, training and support of global and regional DS… more
- Merck & Co. (Rahway, NJ)
- …decisions.3. Defines trial-level requirements for quality data collection and validation at the trial level.Reads and interprets the clinical protocol ... and project-level consistency of database design, data collection, and validation .Facilitates assessment and processing of standards and change requests.Approves… more
- Merck & Co. (Rahway, NJ)
- …of the RY880 building.- The sterile portion of RY880 is in commissioning/qualification/ validation . Successfully delivering on the entire scope of FLEx, including the ... qualification and validation work in the RY880 sterile modality, is a...Sciences and Clinical Supply (PSCS) organization.- This includes operating model , culture, talent development, technology introduction, and compliance.- However,… more
- Merck & Co. (Rahway, NJ)
- …compliance with regulatory requirements.Execute and develop appropriate system validation , change control, and testing documentation.Maintain familiarity with system ... Standard Operating Procedure (SOP) development and review. Direct support of validation activities and all other associated computer system quality functions.… more
- Merck & Co. (Durham, NC)
- …in-process testing and inspections supporting the vaccine manufacturing, validation , and development processesIdentifies and addresses compliance, environmental, ... during project phase we are using a 1A/1B shift model to support operations as we work towards routine...Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions… more
- Merck & Co. (North Wales, PA)
- …analytical datasets, tables, figures, and submission deliverables and perform validation activities following departmental SOPs. This position also focuses on ... in CDISC and ADaM standards, including mappingExperience with Common Data Model (CDM)Expertise in statistics, clinical and data management concepts as applied… more
- Merck & Co. (Durham, NC)
- …While Optimizing Our Base Business)Adapt - Develop Our People, Culture and Business Model to Evolve with a Dynamic LandscapeDiverse Talent - We are committed to ... process equipmentMaintain utility equipment by developing/installing new equipment, completing validation protocols, documenting work using a computerized maintenance management… more
- Merck & Co. (Durham, NC)
- …processesProviding direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expertUnderstands and ... Skills: Direct experience with all levels of the S95 model from ERP to shop floor instrumentation and working...Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions… more
- Merck & Co. (South San Francisco, CA)
- …and retain a diverse, talented team that delivers on target identification & validation and advances CMD pipeline.Education Requirement: PhD, MD, or MD/PhD degree in ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
- Merck & Co. (Durham, NC)
- …and maintenance of clean utility systemsAssists with execution of automation, validation , and additional testing, as requiredResponsible for written documentation of ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
- Merck & Co. (Durham, NC)
- …used in production. Performs sampling/in-process testing supporting the manufacturing and validation process for current process. Provides timely delivery of sample ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
- Merck & Co. (Rahway, NJ)
- …candidates, and/or chemical probes to enable target identification and validation , hit-to-lead, and lead optimization programsProvide scientific mentoring and ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
- Merck & Co. (Austin, TX)
- …policy, scalability, efficiency, reliability, fidelity, flexibility and portability.- - Validation and testing of integrated systems subject to organizational ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
- Merck & Co. (Rahway, NJ)
- …but not limited to: data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
- Merck & Co. (Boston, MA)
- …candidates, and/or chemical probes to enable target identification and validation , hit-to-lead, and lead optimization programs.Provide scientific mentoring and ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
- Merck & Co. (Durham, NC)
- …systems, in partnership with maintenance, technical operations, operations, validation , and quality personnel.Performs routine system monitoring and ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
- Merck & Co. (Rahway, NJ)
- …the vendor to ensure that the computer system operation and computer system validation is completed and maintained, and that the field devices in various locations ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
- Merck & Co. (Durham, NC)
- …and maintenance of equipment/utility systems.Assist with execution of calibration, automation, validation and additional testing, as requiredWork within a team to ... Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions...critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance… more
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