- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendors. This position is also responsible for the delivery of systems , configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety ... systems , and fulfillment of data change requests. ResponsibilitiesChange Requests...cross-functionally and be the voice of CSPV on key system and business process decisions, informed by a deep… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Assist in enhancing user experience and operational efficiency within HCP engagement systems by identifying system gaps and driving technological changes to ... Peer-to-Peer HCP engagement ecosystem by supporting budget management, compliance, system development, operational enhancements, strategic improvements, and performance benchmarking.… more
- Twist BioScience (South San Francisco, CA)
- Twist Bioscience uses high throughput systems , powerful software, and unparalleled product throughput to enable rapid delivery of transformative products for our ... Operational Excellence.Have experience using and/or managing Lab Information Management Systems (LIMS) and Manufacturing Execution Systems (MES).Have strong… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and FDA requirements Understands PSP operations, including program business rules, SOPs, systems used (including CRM, Safety system and PSP dashboarding tools), ... Safety information, including complete and accurate detail processed into the correct systems Quality monitoring activities to include CRM system case… more
- Twist BioScience (South San Francisco, CA)
- …designed, implemented, and maintained to meet regulatory requirements. This role will report directly to the Chief Accounting Officer. Key duties include leading a ... guidance, assessment, and oversight on the governance of Change Management and System Access Controls and provide recommendations on the next level of maturity… more
- Merck & Co. (Rahway, NJ)
- …end-to-end process for their respective global business processes (eg, enabling systems , upstream and downstream transfer of information and assets).Accountable for ... and role-based training associated with core business processes.Partner with Business System Owners on Alignment of Process & Technology.Develop &/or and manage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy: Collaborates with medical affairs and market access teams to inform a health systems strategy to ensure system level acceptance and access to medicines ... the value of customer interactions with NNI. Regularly analyze and report on the effectiveness of implemented strategies, making data-driven recommendations for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality and put proactive measures in place to improve it. Establish KPIs for systems and services, measure and report the results. Support IT Senior Management ... and management of these processes for GxP and Non-GxP systems and services. In this position, the GSM will...are available to deliver the best customer experience.- Manage, report , and communicate on the global performance of owned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manage issues and risks such as scope, budget, and schedule overruns and report to appropriate stakeholders.- Project and Program delivery framework and systems : ... and standardization of program and project management processes, methodologies, and systems in alignment with established and emerging disciplines. Provide and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …business goals.Attend meetings and /or communicates regularly with stakeholders to report batch progress, quality batch review/ release project developments or ... regulatory inspections and internal audits.Ability to utilize multiple electronic quality systems and SAP.Knowledge of cGMP regulations and FDA/EU guidance related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sponsor Oversight Visit process. Provide oversight of the DS Trip Report Review process.Responsible for ensuring oversight of Central Monitoring activities according ... Excellence roleSupport the model in place for DS Trip Report Review via reviewing analytics and metrics of MVR...CRO Oversight leaders to ensure CRAs are updating appropriate systems .Collaborate with Alliance and CRO CRA leadership on major… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical ... Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF activities. This position will interact with global study… more
- Twist BioScience (South San Francisco, CA)
- …Audit Project Sr Manager with Tech industry and public accounting experience. The role will report to the Sr. Director of Internal Audit and be part of the internal ... public company auditing experience that included development, evaluation, and testing systems of internal controlSolid understanding of Sarbanes-Oxley (SOX 404) and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a subject matter expect on clinical and medical informatics software and system development with customers in collaboration with the research partnerships function ... broader adoption and optimal use of clinical informatics tools. Relationships This individual will report to the VP of CDSE and serve on the CDSE Leadership Team.… more
- Merck & Co. (South San Francisco, CA)
- …enabling technologies and methodsEnsure high-quality data analysis and timely report generation to project teamsProperly document experimental designs, findings, and ... and immuno-oncology cellular models, such as those with primary cells, co-culture systems , and 3D spheroids/organoidsDemonstrated proficiency in a wide range of cell… more
- Lundbeck (Walford, IA)
- …in an efficient and professional manner Maintenance of the Product Range Management system Support the Business Analyst with the process and models for Demand portal ... that Lundbeck's products reach our patients efficiently and reliably. You will directly report to the Head of Finance and Business Operations Lundbeck UK &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also lead a non-project initiative in support of these objectives. This position will report to the Sr Director, Group Leader, GPM&L or the Executive Director, US ... support scenario planning.Maintains project status in the project management information systems . Prepares scope change proposals and stage gate proposals for formal… more
- Merck & Co. (Rahway, NJ)
- …executed efficiently with timely and high-quality deliverables.Effective analysis and report programming development and validation, utilizing global and therapeutic ... projects (data, analyses, tables, graphics, listings); working with SAS systems and statistical databases; designing and developing complex programming algorithms;… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the facility and coordinate with site management for repairs. Report and address any unsafe conditions or environmental concerns.Key Relationships:Ability to ... requirements and breakdowns.cGMP manufacturingMaintenance and facilities managementComputerized maintenance management systems (CMMS)Quality Management knowledge, including Change control, Deviation, and… more
- Merck & Co. (Durham, NC)
- …future testing capability at the Durham site.-- The successful candidate will report to the Associate Director, Laboratory Operations to lead start-up new ... start-up testing in new laboratories using principles of our Production Systems , Lean Laboratories, and GMP requirements.- GENERAL PROFILE: Work cross-functionally… more
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