- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key...reporting capabilities, incl. creating reports and dashboards of key regulatory data/metrics from across systems , leveraging technical… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... support in software validation and migration activities relating to new or existing systems in Regulatory AffairsRequired Skills5 years of Regulatory … more
- Aequor (Newbury Park, CA)
- …and deliver training materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management & Systems documents ... This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works...do. Detail oriented, to be able to monitor data quality . Comfortable learning new systems /processes. Someone who… more
- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event,… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This position is...Acts as SME and local Super User for NN systems , specifically for the Change Control and Deviation modules.… more
- Aequor (Libertyville, IL)
- …manufacturing domains, and supporting technology like manufacturing and supply chain ERP systems Working knowledge of regulatory requirements and how they relate ... incident, problem and change IT operational events (ie ServiceNow). Knowledge of IT systems such as ERP, OSI PI, Client, LIMS, ServiceNow, Celdox and Veeva.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The ... ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.Reviews… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global… more
- Catalent (St. Petersburg, FL)
- …responsibility for Quality aspects including but not limited to Quality Systems , Finished Product Batch Release, Training, Internal/External Audits, ... and to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management… more
- Catalent (St. Petersburg, FL)
- …phase, technical transfers and routine production.Provide support to internal, client, and regulatory audits.Engage in monitoring quality systems to maintain ... Manager , QA (Product Development)Position SummaryThe Quality ...St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems… more
- Merck & Co. (Durham, NC)
- …experienceGood Manufacturing Practice (GMP)-regulated manufacturing environmentElectronic manufacturing systems (eg PAS-X, SAP, Delta-V, etc.)Interacting with ... Job DescriptionThe role of Operations Manager at our Company's Durham facility is a...they must become proficient in the use of manufacturing systems and knowledgeable of site procedures in order to… more
- Aequor (NJ)
- …studies during phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery of ... 100 % remote Manager prefers local candidates (will consider non local...Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with multiple Novo Nordisk's internal functions such as Marketing, Field Execution, Field Systems , Advanced Analytics, IT, Legal, Regulatory , as well as external ... you in? Are you ready to experiment with us? The Position The Manager , NextGen Customer Engagement will support Novo Nordisk's strong commitment to its customers… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... and performing data interpretation; and supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
