- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to align system development with business and regulatory expectations. Review systems for affiliate companies to assess data integrity and implement ... validation of IT services and determining audit targets for GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director, Data Quality and… more
- Merck & Co. (Rahway, NJ)
- …that enable new organizational capabilities.Decision Science is seated within the Data Science and Scientific Informatics (DSSI) team of Research and Development ... and design solutions. Our solution process involves mathematical modeling of data and processes implemented through efficient and modular computational tools to… more
- Raytheon (Hurlburt Field, FL)
- …test personnel, requirements officers, logistics managers, and other contractors to develop report and provide solutions to mission system problems and conduct ... create a safer, more secure world.The CV-22 SSA Senior Systems Engineer will join our Systems Engineering...analysis, and test of current and emerging CV-22 integrated system requirements. The candidate will work closely and consult… more
- Merck & Co. (Rahway, NJ)
- …time, across the globe.Summary, Focus and PurposeThe Director of GMP Compliance will report to the head of the Global Quality Compliance Support organization.- The ... in a pharmaceutical or biotechnology manufacturing site.--Strong background in data analyticsDemonstrated ability to creatively use multiple methods of analysis… more
- Merck & Co. (Rahway, NJ)
- …This role requires excellent analytical, negotiation and communication skills.This role will report directly to the Chief of Staff to the General Counsel & ... leading RFP projects, managing timelines, preparing reports and analyzing data , creating presentations, and coordinating deliverables. Respond to inquiries from… more
- Merck & Co. (Boston, MA)
- …working with scientific software development, Pharmaceutical sciences, Quantitative systems pharmacology, Model-Based Drug Development-, or scientific data ... Software Development, Stakeholder Engagement, Stakeholder Relationship Management, Strategic Planning, System Designs, Systems Development Lifecycle (SDLC)Preferred Skills:Job… more
- Merck & Co. (Rahway, NJ)
- …business transactions. And will also provide operations solutions reviewing and analyzing system and passive data governance reports to ensure high quality ... data and timely and complete synchronization between systems . Acts to resolve all issues and discrepancies as...packages. Strong understanding of Enterprise Process Management to troubleshoot report /input templates (in cases of master data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review Case Report Form (CRF) annotation and SDTM dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… more
- Eisai, Inc (Nutley, NJ)
- …analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability ... and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice...carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for… more
- BioAgilytix (Durham, NC)
- …-driven decision-making across BioAgilytix, by leveraging enterprise systems and data visualization tools to report critical business information. This role ... is responsible for gathering and integrating data to provide actionable insights that support sales operational...and machine learning. Proficiency in Salesforce or other CRM systems is required. Strong understanding of financial and sales… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Primary responsibilities include validation protocol execution (IQ, OQ, PQ & PV), data analysis and final report preparation for utilities, equipment and ... in the pharmaceutical or biotechnology industry Experience preparing protocols, executing data analysis, and report writing Experience preparing protocols,… more
- Repligen (Waltham, MA)
- …components.Set up, configure, and operate hardware units during testing cycles.Document and report defects using issue tracking systems (Jira); work closely with ... hardware engineers, and product management teams to validate that our integrated systems meet user expectations and quality standards. You will also be encouraged… more
- Raytheon (Tucson, AZ)
- …integration, verification, and field qualification testing to ensure the system under test performs according to specifications/requirements.Perform data ... solves tough, meaningful problems that create a safer, more secure world. In Systems Engineering and Test Capabilities (SETC) we integrate, verify, and validate our… more
- Genmab (NJ)
- …expected to become Subject Matter Experts (SMEs) for assigned processes and systems .The primary location for this role is Utrecht, The Netherlands. Candidates ... and study-related materialsDevelop and maintain the study TMF PlanClinical Study Report (CSR) Management:Support filing appendices of Clinical Study Report … more
- Eisai, Inc (Mckinney, TX)
- …with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers (healthcare ... exchanges and interactions with identified KOLs.Present clinical, scientific and economic data on Eisai's products and relevant therapeutic areas to population-based… more
- Genmab (NJ)
- …Advances this effort through the coordination and development of data -driven early indication and program assessments, study-level feasibility assessments, robust ... delivery for all stages of global feasibility. Ensure standardization in use of data , tools and processes to inform risk-benefit decision making at TA, program and… more
- Merck & Co. (Rahway, NJ)
- …partners, designs studies, authors study protocols, develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific ... needs of clinicians, payers, policymakers, HTA/reimbursement agencies and health systems globally. The ability to participate and lead cross-functional teams… more
- Merck & Co. (Rahway, NJ)
- …negotiating costs, executing contracts and ongoing contract management. This role will report to the Associate Director, Clinical Trial Central Labs to support high ... collaboration with the CDSP team; ensure contracts are filed to the appropriate systems and tracked internallySourcing - to assist in creating and executing RFIs,… more
- Eisai, Inc (Nutley, NJ)
- …specification, data management plan, final database validations, final study report . Performs statistical analyses. 10%3. Influences the proper use of statistics ... he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs… more
- Merck & Co. (North Wales, PA)
- …Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise ... the entire product lifecycle. - Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and… more
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