- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data Integrity strategy and promote a quality culture throughout the Global RD ... and integrity initiatives.Develop and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those… more
- BioAgilytix (Durham, NC)
- …and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, ... sharing between systems, with a focus on operational efficiency and data integrity . Data Quality & Compliance Automation: Use Robotic Process Automation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Ethics & Compliance (E&C) Monitoring & Auditing function, prioritizing data analytics, trends, and insights in alignment with evolving government expectations, ... NNI's risk management program. This role leverages innovative technology, data analytics and data insights to drive...program awareness, and fostering a culture of ethics and integrity across the organization. It also plays a pivotal… more
- Genmab (NJ)
- … (eg, labs, eCOA, biomarkers, imaging).Serve as SME in protocol quality, lab data integrity (central and local), and management of protocol deviations across ... Management. This individual is accountable for driving the strategy, quality, and integrity of external data across the clinical trial portfolio. This role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process improvements and other initiatives. Proactively identifies and manages risks to data quality, data integrity , programming and reporting deliverables, ... to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role....and in-house operating models. Is accountable for the quality, integrity , and timely delivery of all external data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technological and data innovation, maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will ... Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, and is tasked… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise in GxP regulations, CSV, 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system architecture, cloud solutions, ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (South San Francisco, CA)
- …Research and Development Sciences IT (RaDS-IT) of our Company is seeking a Lead Data Scientist for Representation Learning.Our team is a diverse collection ... and curate large-scale datasets relevant to molecular and protein design, ensuring data integrity and accessibility for team members.Collaborate closely with… more
- Aequor (Swiftwater, MN)
- …validation, and master data management - Familiar with 21CFR part 11 data integrity best practices in pharmaceutical environment - Excellent written and ... support will include supporting Business Administrators in, updating master data for new and existing products, updating master ...verbal communications skills and the ability to lead and participate in teams - Experience or familiarity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in terms ... release, data review and cleaning, database lock), to ensure data quality/ integrity and regulatory complianceEnsures that Data Management Plans are… more
- Raytheon (Andover, MA)
- …wet and dry etching, lift-off techniques, photolithography, metrology, process characterization, foundry data integrity , and large data analysis methods.The ... Solutions (AMS) Department is searching for a Semiconductor Backside Via Process Lead to join our III-V compound semiconductor foundry team fabricating gallium… more
- Twist BioScience (South San Francisco, CA)
- …biomanufacturing operations. This critical role will drive efficiency, quality, and robust data integrity within a highly automated environment. The effective ... LIMS, QMS), and ensure compliant data flow across the biomanufacturing ecosystem. Data Integrity & Reporting: Architect and ensure the accuracy, integrity… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionContainer Closure Integrity Testing Lead , Associate Principal Scientist, Analytical Research & Development The Analytical Research and Development ... data entry, data review/approval, and author analytical reports or data summaries.Troubleshoot and lead any investigations associated with GMP testing… more
- Merck & Co. (Durham, NC)
- …record of analytical skills, problem solving and attention to detail Strong data integrity acumen Strong understanding of manufacturing principles/ processes and ... Information Technology teams. Experience with regulatory audits and working knowledge of data integrity principles. - Understanding of Lean Manufacturing /Six… 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 ... build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Merck & Co. (South San Francisco, CA)
- …codified its legacy for over a century. Our success is backed by ethical integrity , forward momentum, and an inspiring mission to achieve new milestones in global ... Our ability to impact the lives of patients worldwide depends on the integrity , creativity, humility, and scientific acumen of our team. We are creating a… more
- Merck & Co. (Durham, NC)
- …Information Technology teams.Experience with regulatory audits and working knowledge of data integrity principles. -Understanding of Lean Manufacturing /Six ... production.- Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP,… more
- Eisai, Inc (Boston, MA)
- …due to Alzheimer's disease (AD) or mild AD. The Area Business Leader (ABL) will lead a team of Neurology Account Specialists (NAS) that are part of a diverse team ... aspects of Alzheimer's disease and the competitive landscape in which they will lead . Additionally, the ABL will be responsible for ensuring their NASs educate… more
- Merck & Co. (Rahway, NJ)
- …and provide solutions to meet their needs.The Director, Global Market Access Oncology, lead the pipeline TROP 2 asset in combination launches for across multiple ... solid tumors. In this capacity, the candidate will lead all Oncology global market access and pricing activities, including asset access strategy work, development… more
- Genmab (NJ)
- …of a dynamic, collaborative team that values innovation, quality, and scientific integrity ? At Genmab, we are seeking a passionate and experienced Senior Medical ... in a fast-paced environment, are motivated by high standards, and can lead projects with both independence and collaboration. You're proactive, flexible, and highly… more
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