- 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 ... and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …allow access to unapproved medicines for patients with unmet medical needs.- Quality Management and Continuous Improvement: Provide guidance to teams during ... research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology… more
- Merck & Co. (Rahway, NJ)
- …assigned protocols and sites in a-country.-Under the oversight of the CRA manager the person ensures compliance of study conduct with-ICH/GCP and country ... regulations, policies and procedures, quality standards and-adverse event reporting requirements internally and externally.Acts as primary site contact and site … more
- Aequor (New York, NY)
- …an occupational nursing professional Minimum experience of 1-3 years in case management , utilization review and/or quality assurance Experience in episodic care, ... counseling of adults Proficiency in use of electronic medical record keeping systems desirable BLS certification required Optional: Case Management and COHN-S… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... Biostatistics and Data Management team and performs programming tasks, including SDTM and...collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global… more
- Merck & Co. (Rahway, NJ)
- …into a roadmap of prioritized improvements to our infrastructure (eg knowledge management , training, and enabling systems ) and drive initiatives on that ... Job DescriptionAssociate Director, PMO People & Process LeadGlobal Project and Alliance Management (GPAM) sits in the Research & Development organization at our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective ... DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems .Company Sponsored Studies (CSS) ... milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies...and tools to achieve excellence in trial operations and management .Monitor and ensure compliance and highest quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …EU preferred)2 or more years Familiarity with pharma and regulatory information management systems (RIMS); Veeva Vault experience preferred. Travel Ability to ... rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global...quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and ... Relationship Management - Leads contract related communication with vendors. Respond...spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …network to influence across the organization.Manages project status in the project management information systems and communicates risks/issues to GPM senior ... project or be partnered with a more senior project manager in support of a larger, more complex drug...drafts stage gate proposals for formal presentation to senior management .Generates and maintains high quality risk … more
- Novo Nordisk Inc. (New York, NY)
- …the diabetes educator will interact with key health system departments including: quality , care management , population health, diabetes treatment centres, and ... the system population. Internally, the Diabetes Educator reports to the Health Systems Diabetes Educator Manager (HSDEM). The Diabetes Educator primarily aligns… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trials improvement/innovation projects for NACD & Novo Nordisk (eg, Health Systems , Contract Research Organizations & Site Management Organizations etc.) ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Position Provides tactical leadership to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO).… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission related… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across CMR to plan, ... 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... This individual will be responsible for all technical and program management scope to drive activities ranging from strategic/business plans to managing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... responsible for agile execution and support of new capabilities, platforms, and systems within Novo Nordisk in partnership with internal stakeholders and external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …writing skills Must have some SQL or programming skills Good knowledge of Account Management for Market Access accounts, Health systems , HCPs and business rules ... Position The Senior Analyst will be the Master Data Management (MDM) primary Subject Matter Expert (SME) for Market...The role will also serve as backup to the Manager for Data Stewards of Patient, Customer and Product… more
