- BioAgilytix (Boston, MA)
- …client data quality processes. Through your technical reviews of raw and processed data , you will ensure data integrity standards are met across various ... need them.Our clients trust us to deliver excellence in data and bioanalysis and in this role and you...for candidates who have practical regulatory experience with bioanalytical data in a corporate GxP setting. This role is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …frameworkPartner with RD Excellence to support ongoing process improvement related to data governance to ensure data integrity , quality, consistency, ... around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the...Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will… more
- Merck & Co. (Rahway, NJ)
- … Data Management and Standards (GDMS) within the GCTO organization. GDO focuses on data collection, data review and integrity throughout the lifecycle of ... Here, you have that opportunity. You can put your integrity , knowledge, imagination, skill, and teamwork to work in...clinical trials.-Clinical trials provide the required data which allows Merck to bring new prescription medications… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and resolve issues related to Veeva CRM and Omnichannel Marketing functionality, data integrity , and system performance. Stay up-to-date with industry trends ... technical expertise related to the configuration of Veeva CRM and perform data analysis and configuration deliverables related to business processes. Conduct user… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …(URS) and oversee the management of equipment qualifications. Provide support for data integrity assessments within the laboratory. Take the lead in ... regular reviews of system audit trails / periodic review to ensure data integrity and compliance. Manage equipment access rights and perform periodic reviews to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documents for DCR-PHXC, and other programs Participate in the analysis and interpretation of data , ensure integrity of trial data , and assist in reporting ... clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility position, the candidate will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical data review excellence with a focus on patient safety and data integrity , site scientific engagement, and HA responses. Interactions with the ... ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The… more
- Merck & Co. (North Wales, PA)
- …the Company Product Literature Database to ensure the maximum performance, reliability, data integrity , security, copyright compliance, and precision and recall ... database. Leads end-user and system application development Participates in data processing, harmonization, deduplication, and standardization activities Participates in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant files.Research and obtain further information for incomplete documents.Comply with data integrity and security policies.Maintaining open and effective ... analyzing, and improving identified processes within the quality organizationPerforming data analysis for established metrics and identifying potential new… more
- Novo Nordisk Inc. (Durham, NC)
- …Support training planning and development of technicians and analysts Review lab generated data to ensure data integrity and timely reporting for ... batch release as needed Facilitate problem solving, investigations, and process improvements Responsible for ensuring laboratory areas are inspection ready Responsible for supervising their team to include performance management, coaching, development,… more
- Merck & Co. (Durham, NC)
- …Information Technology teams.Experience with regulatory audits and working knowledge of data integrity principles. -Understanding of Lean Manufacturing /Six ... facility.- Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and analysis of VoC data from various sources and touchpoints. Ensure data quality and integrity across VoC initiatives Customer Insights: Analyze customer ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… more
- Aequor (Devers, TX)
- …oral communication skills are required. Background in problem solving Knowledge of Data integrity principles Proven attention to details Comfortable working in ... deliverables, in a remote working environment Able to interpret complicated data and make sound decisions, Independently This position will regularly interact… more
- Sun Pharma (Taro Pharma) (Billerica, MA)
- …required. Serve as a leader within the QC group and as a knowledge resource ( data review, electronic review, data integrity , GDP) within the companyAny Other ... per established procedures and methodology Area Of Responsibility QC Testing data review of products, raw materials, stability lotsOversee and continuously improve… more
- BioAgilytix (Durham, NC)
- …the supervision of the Manager, Sample ManagementEnacts process improvementsEnsures data integrity and traceabilityWrites/reviews Sample Management SOPs and ... GxP-regulated environmentSupervisory ResponsibilitySample Management TechniciansSample Management Specialists May supervise Data Management Specialists and/or Lab AssistantsSupervision ReceivedInfrequent supervision and… more
- Eisai, Inc (Nutley, NJ)
- …consultancy on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system ... Requirements Bachelor's degree in associated functional disciplines including IT, Data Sciences and others.Software development familiarity with both Agile and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity Executes, owns, assesses and participates in the ... creation, revision and review of change controls, SOPs, and other documentation Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews Requirements A minimum of a Bachelor's Degree in… more
- BioAgilytix (Durham, NC)
- …Must understand software and file permission settings as it pertains to data integrity and computer system validation.Detail oriented and highly ... departments and functional groupsSupervisory ResponsibilityMay supervise additional automation and data management support staff in the futureSupervision ReceivedInfrequent supervision… more
- Catalent (Philadelphia, PA)
- …harmonization of worldwide Quality operating procedures as needed. Provides leadership for Data Integrity and Computer System Validation documentation review and ... approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle. Other duties as assigned.The Candidate: BS or BA in Chemistry, Biological Sciences, or other related scientific discipline or equivalent experience. 15 +… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementation and management of tools or platforms for collecting customer feedback. Ensure data quality and integrity within the VoC program Customer Insights ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… more
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