- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to ... of 3-5 years' experience in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance. required Experience Qualifications4 or… more
- Merck & Co. (Rahway, NJ)
- …with RCQM. -The role requires the ability to properly oversee and/or lead local quality operations to implement local/regional/global processes/procedures, ... is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. ... operations in a controlled GMP environment. The lead QC Microbiology Data Reviewer will also...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Maintain detailed knowledge of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical ... Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to… more
- Merck & Co. (Rahway, NJ)
- …pipeline progression and cross-functional execution by integrating planning capabilities, data science / engineering, and insight generation into our Research ... & Development division.The Associate Director, PMO People & Process Lead , is a unique role that will be heavily...the training forum; accountable for curating and defining a quality annual calendar of topics that achieve the purpose… more
- Merck & Co. (Rahway, NJ)
- …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the ... to enable flexibility and speed of the Company's pipeline. This role will lead equipment development and maintenance activities -and support facility operations ,… more
- Merck & Co. (Rahway, NJ)
- …Template asset, delivering enterprise-level capabilities through harmonized business processes and data .-The team is responsible for the operation of all our ... the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all...a DEV/OPS SAP technology team, responsible for development/ governance/ operations of the enterprise-wide technical SAP ERP asset. Their… more
- Insmed Incorporated (San Diego, CA)
- …as quality initiatives and therapeutic area training (TAT).Oversees daily operations in the laboratory with respect to troubleshooting instrumentation, out of ... unit to ensure efficient and effective scientific and administrative operations . Operates, maintains, and repairs clinical laboratory equipment within scope… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …owners to conduct comprehensive analysis on all GMS material management aspects addressing data creation, data quality , governance needs and dealing with ... leader, with strong understanding of Manufacturing & Supply Chain Management operations , who can translate operational and technical data requirements,… more
- Merck & Co. (Rahway, NJ)
- …depth and breadth of scientific, technical, and operational experience to lead and support facility operations , process development activities, compliance ... drive overall success of the pilot plant. The Facility Lead position reports to the Director of Operations...compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Transformation Lead is responsible for supporting CMR transformation by ensuring… more
- Merck & Co. (North Wales, PA)
- …of collection, international shipment, processing by internal/external labs and data transfer for biospecimen- based studiesParticipate in quality ... Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study… more
- Eisai, Inc (Nutley, NJ)
- …strengthen compliance with GDPR, HIPAA, CSL, and other relevant security and data privacy standards. Your responsibilities span security operations , risk ... and respond to incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, on regular basis ... agreed quality standards and timelines and that quality of data is suitable for regulatory...propose solutions, or bring to the attention of the operations lead of study team lead… 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 ... ready to experiment with us? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a diagnostics and precision… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Data Enrichment services, including data standardization, natural language processing o Data Quality operations that standardize data definitions, ... data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and...fashion Lead and work with functional business data stewards on data quality … more
- Eisai, Inc (Nutley, NJ)
- …colleagues (business relationship managers, application leaders and infrastructure operations ) to establish a methodology for consistent services ... leadership to managed services vendors to drive performance improvement, quality , and cost optimization.Drives a culture of continuous improvement that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality rules and data governance ... with cross-functional stakeholders (incl. RD / Corporate teams) to define data ownership, and data quality requirements.Continuously assess… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and complaint product supply. Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and ... based in Raritan, NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality ...within facility Perform internal housekeeping audits Perform analysis on quality indicating data and identifying trends Provide… more
- Merck & Co. (Rahway, NJ)
- …incumbent is responsible to support the operational functions of the Third Party Quality Management group, which provides quality oversight of suppliers and GMP ... independently execute on the following:Engages in strategic planning activities across the Quality Unit and participates in project planning and activities of self… more
