- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ... audit targets for GxP systems.ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director , Data Quality and Integrity...or Medicines required. An advanced degree such as a Master 's degree preferred, PhD or other advanced degree in… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAssociate Director , Data Science - US Vaccines The Associate Director Data Science will be responsible for developing and communicating ... data -driven and actionable insights that drive greater customer and...strategiesBe accountable for ensuring delivery of analyses with high quality standards, timeliness, compliance, and excellent user experienceComprehend the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of external data -- acceptance, storage, and delivery activities to ensure complete, high- quality data is available for use by clinical study teams in a ... around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides...and other initiatives. Proactively identifies and manages risks to data quality , data integrity, programming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery ... teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of laboratory data deliverables to support drug development processes… more
- Eisai, Inc (Boston, MA)
- …provide a holistic view of ongoing projects, facilitating informed decision-making.Model Training & Data Quality Assessment: Assess the quality of data ... Data Operations Group at Eisai, Inc. is looking for Associate Director - Data Scientist/Programmer to create insightful AI powered instantaneous dashboards.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... role reports directly to the Vice President of Enterprise Data & Advanced Analytics (ED&AA) and serves as a...all Novo Nordisk policies, procedures, and the Novo Nordisk Way.Qualifications: Master 's or Ph.D. degree in a quantitative field (such… more
- Merck & Co. (North Wales, PA)
- …should have strong managerial experience, a high-level strategic understanding of regulatory data governance and master data management principles, dataflows ... of the value and criticality of the need for Master Data Management at an enterprise level...region with responsibility of meeting the reporting deadlines and quality measures specified in local SOPs- - Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision ... a reasonable accommodation. Education Qualifications (from an accredited college or university)- Master 's degree in life sciences, data science, statistics, or… more
- Merck & Co. (Durham, NC)
- …External Partner site(s). Maintain adherence to terms in the Supply Agreement and Quality Agreement - ensuring alignment with the Master Supply Agreement (MSA). ... Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... pull you in? Are you ready to experiment with us? The Position The Director , Consumer Marketing, will be a pivotal driver in shaping an insights-driven consumer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …metrics.Implement and manage robust data governance processes to ensure ongoing data quality and security, facilitate or collaborate in regular audits ... Data Governance: Experience with data governance processes to ensure ongoing data quality and security, supported by regular audits, data maintenance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with… more
- Eisai, Inc (Nutley, NJ)
- …to ensure the quality of CRO deliverables and on QA of data outputs. 10%5. Functions as lead statistician in global registration trials and manages all ... he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respective cross functional groups, CROs, Affiliates in order to ensure high data quality and proactive detection and resolution of issues.External ... research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …settings and ensuring treatments are cost-effective and have a positive impact on patient quality of life. This involves analyzing data to inform decisions about ... tumor areas through various means, including but not limited to extraction of data gaps, collecting additional evidence from literature to support product value, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of ... meet the qualifications below with or without a reasonable accommodation. Education: Master 's Degree in statistics or biostatistics requiredPhD in statistics or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... us? The Position The Senior Manager - Market Access Insights works with the Director - Market Access Insights to explore key market access topics of interest and… more
- Genmab (NJ)
- …of data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems. This role reports to ... the Director , Team Lead of Clinical Programming.Responsibilities/tasks - including but...with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrityCreates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the ... Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional Global… more
