- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with US FDA and other international bodies.Support the global quality annual objectives, strategic initiatives to deliver against the business plan.In close ... the management representative for all key health authority inspections ( US FDA, EU EMEA, MHRA etc.,).Develop and maintain an...lead as the Head of PV QA with Quality Reviews of respective product profile to ensure appropriate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …value through human-centered design pull you in? Are you ready to experiment with us ? The Position The Business Performance Management Lead will play a pivotal ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …driving value through human-centered design pull you in? Are you ready to experiment with us ? The Position The Business Excellence Lead will play a pivotal role ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us ? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an insights-driven HCP marketing strategy and KOL ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …driving value through human-centered design pull you in? Are you ready to experiment with us ? The Position The HCP Experience Lead will play a critical role in ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experiment with us ? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a diagnostics and precision health ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …driving value through human-centered design pull you in? Are you ready to experiment with us ? The Position The Consumer Strategy Lead will be a pivotal driver in ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …driving value through human-centered design pull you in? Are you ready to experiment with us ? The Position The Brand Strategy Lead is pivotal in developing brand ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the global regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, ... merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of...human health starts here and that patients rely on us . We're changing lives for a living. Are you… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations.The Senior… more
- Tris Pharma (Monmouth Junction, NJ)
- …Documentation Practices (cGDPs) within pharmaceutical industryExperience implementing and managing quality systems and processesFamiliar with US FDA guidance ... Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines… more
- Catalent (Philadelphia, PA)
- …Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, ... incoming material quality , and/or distribution quality , including quality oversight for material management of materials at Catalent-Philadelphia. Assist in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …labeling and associated documents (including cartons and external packaging in the US ) for assigned Daiichi Sankyo products. This position ensures that draft ... on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either...by managing labeling development or approval for either the US or EU. Preparation of updated Core Data Sheets,… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...SOPs related to batch record documentation and release.Act as lead investigator for all Problem Reports regarding batch record… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....clinical trial sources for all Novo Nordisk Inc (NNI) US marketed products (drugs and devices). To support workflow… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team ... quality , reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes ... defining regulatory data standards, data quality rules and data governance processes across GRA, and...visibility across regions and sub-functionsPartner with the Process Excellence Lead and others to identify process improvements based on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …learning and personal development. Are you ready to maximize your potential with us ? The Position This role is responsible for the volume forecasting of the ... total US business (diabetes, obesity and rare diseases), supporting evidence-based...optimizing clarity of the overall sales forecast process and lead the continuous development of the volume forecasting environment… more
