- Merck & Co. (Rahway, NJ)
- …and enhance the efficiency of our clinical research operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct the development and maintenance of ... seeking a highly qualified and experienced Associate Director in Data Management to lead our data...numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data… more
- Merck & Co. (Rahway, NJ)
- …candidate will lead a cross functional insights team that spans data science, market research, data strategy, and measurement.The preferred candidate should ... Job DescriptionThe Associate Director Data Science will be responsible for developing and...be an independent contributor as well as be a lead partner in helping to scope, design, and deliver… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform ... around rare diseases and immune disorders. Summary The Manager, Data Programmer is a member of the Biostatistics and...collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are ... and external cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and consistency within and across programs on an ongoing basis to ensure data quality and adherence to established coding conventions. In collaboration with ... resultant coded data . Proactively identifies potential risks to medical coding quality , integrity, and timelines for assigned studies and escalates issues to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …incorporating relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ManagementEstablish and enforce robust ... and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS...privacy.Implement processes to regularly test, audit and validate HR data to maintain high data quality… more
- Merck & Co. (Rahway, NJ)
- …technology solutions. The Enterprise Architecture (EA) team is helping to lead this transformation. Our vision is to provide strategic technology decisions ... areas, and actively contributing to Enterprise Architecture's vision of high- quality , light touch architecture governance. Responsibilities: Architecture:Delivering and documenting… more
- Merck & Co. (Rahway, NJ)
- …is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision ... a team of crystallization subject matter experts, the Crystallization Lab Lead collaborates with cross-functional teams to ensure small molecule Active… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and… more
- Merck & Co. (Rahway, NJ)
- …Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications ... for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …benefit of patients and global human health.This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders. ... with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the data into analysis/modeling datasets, and… more
- Merck & Co. (Rahway, NJ)
- …internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working ... not limited to:--Interacts closely with key partner organizations (as a lead Global Clinical Supply Planning program representative) such as clinical development,… more
- Merck & Co. (Rahway, NJ)
- …and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that ... division and IT, including scientists, engineers, IT architects, infrastructure, quality , vendors in building, optimizing, and troubleshooting the OT automation… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be ... remove barriers on portfolio or scientific prioritiesEvaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction ... protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and… more
