- Insmed Incorporated (San Diego, CA)
- …act as an analytical lab representative on a CMC team.Perform quality management activities such as deviation, CAPA, change control, investigation of ... OOS, OOT and anomalous results within the company QMS according to established procedures.Participate in establishing sample plans, managing in-process and release test samplesParticipate in establishing stability plans, managing stability tests and reference… more
- Insmed Incorporated (Bridgewater, NJ)
- …they follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and ... York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …difference? The Position Responsible for upholding and promoting the Novo Nordisk (NN) Quality Management System (QMS) as the framework that enables the company ... mitigate or resolve, for example across various topics, such as clinical trial management , deviation handling, and product quality Develop, execute, and maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that standardize data definitions, implements quality rules, and aligns with quality management system required- 4 or More Years Some hands-on experience ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management , lineage capabilities and the data governance processes… more
- Merck & Co. (Miami, FL)
- Job Description Position Description: The Chronic Care Representative (CCR) is the primary point of contact for a variety of customers within their assigned ... as physicians, physician assistants, nurse practitioners, nurses, pharmacists as well as quality directors and office managers.-- Within their geography there are a… more
- Aequor (New Brunswick, NJ)
- …review investigations, interpret results, and generate technical conclusions consistent with Quality management principles - Good Knowledge of evaluation and ... priority requests. - Advanced knowledge of Microsoft office applications , LIMS, Quality Management system (eg TrackWise or Veeva), Statistics software (eg… more
- Merck & Co. (Cincinnati, OH)
- Job DescriptionThe Chronic Care Representative is a key member of the local Customer Team that works collaboratively with our Company's field-based employees such as ... well as other members of our Company's extended team.The Chronic Care Representative 's responsibility will be dependent on manager discretion based on the priorities… more
- Catalent (St. Petersburg, FL)
- …Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. ... investigations, change controls, audit tasks, corrections, and effectiveness checks. Generate quality metrics, trackers, and reports for management and clients… more
- Insmed Incorporated (Bridgewater, NJ)
- …Program and the reason we are seeking top talent for the role of Director, Case Management . Patients are the core of what we do here at Insmed, and we are looking ... want to hear from you! As Director of Case Management , you will be a key member of the...days in the office and working remote as necessary.ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... the CMR training strategy. Serve as the CMR Training representative ; Liaise with global and HQ counterparts to promote...; Liaise with global and HQ counterparts to promote quality and consistency across regions. Ensure compliance with SOPs,… more
- Catalent (St. Petersburg, FL)
- …compliance enhancements/improvements and leading project to deliver solutions.Collaborates with management and supervisory personnel from operations, quality ... I. Department Overview: The Quality Assurance Department is responsible for providing leadership... system documents as directed or assigned by QA management .Liaise with customers to ensure customer requirements are satisfied.Facilitate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... and content, and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant therapy area for all other Novo… more
- Insmed Incorporated (Bridgewater, NJ)
- …and maintain data governance practices to enhance data quality and reliability.QualificationsQualificationsBachelor's degree in Supply Chain Management ... of contact for partners, ensuring on time, compliant, day-to-day shipment management , monitoring vendor performance through KPIs, and tracking budgets. The role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and...Phase 3 registrational study(ies); Develop prospective contingency plans for management of key risks in a large study or… more
- Merck & Co. (North Wales, PA)
- …and post-marketing development stages.-Key responsibilities for the position:Serve as a statistical representative and core member in the Risk Management Safety ... group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and Development… more
- Insmed Incorporated (Bridgewater, NJ)
- …the ED will be responsible globally for executing the safety and risk management activities for one or more clinical development or marketed products throughout ... will provide coverage for the VP, DSPV during his absence.ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited to,… more
- Merck & Co. (Rahway, NJ)
- …Development Statistics.Interacts with Clinical, Regulatory, Statistical Programming, Data Management , and other company Research Laboratories Scientists in designing ... a specific disease area. Primary activities :Serves as statistical representative and lead in the cross-functional teams for the...to ensure that the data evaluated are in high quality and satisfy analysis requirements.May lead a team of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on ... that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that… more
- Insmed Incorporated (Bridgewater, NJ)
- …technical support, proactive problem-solving, and strategic direction.ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be ... IT support team, including hiring, training, mentoring, and performance evaluation.Ensure high- quality customer service and timely resolution of IT issues for… more
- Daiichi Sankyo, Inc. (Munich, ND)
- …lecture series. This position is globally focused to ensure network sites are representative of DS global vision. The Network Lead will assist to drive strategy, ... studies, functional lines including, global regulatory operations, biostatics, data management , clinical science and clinical operations. The Network Lead will… more
