- 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
- Merck & Co. (Rahway, NJ)
- …training-needs to CRA manager and/or functional vendor and internal management as-needed.Performs Quality control visits as required.Leads local study teams ... Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role...is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with… more
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... so everyone can bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's DSCS Digital… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …product owners to deliver solutions using Agile methodologies.Collaborate with systems engineers, software engineers, data services, architecture, test engineers, ... of both internal and external resources located on and offshore; manager project in Agile (Scrum) development methodology; planning, organizing, and conducting… 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
- 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
- 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)
- …review issues log, develop risk mitigations strategies and ensure all systems are operating well as designed. Ensures compliance with internal controls ... of all Financial Disbursements technology applications and other linked systems . Translates business / functional goals into appropriate Financial Disbursements… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces for Millennials™ lists.OverviewThis position is responsible for supply chain management and purchase of raw materials, components and services consistent ... with specified levels of quality , delivery, price and total cost. This position will support the Associate Director, Supply Chain & Logistics in managing a network… 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
- 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
- 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
