- Novo Nordisk Inc. (Plainsboro, NJ)
- …eg routine networking through membership in industry association(s). Essential Functions Sales Operations Partner Drive value creation and link quality to ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....the Commercial business unit and the Strategy, Finance, & Operations business units, develops and executes relevant sales force… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, ... Services, Senior Leadership, etc.) on deviations and PQC investigations relating to production operations , quality operations oversight and quality … 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 ... to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ownership to position & deliver upon near & mid-term NACO… 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 ... systems within Novo Nordisk in partnership with internal stakeholders and external vendors. Specifically, this role will develop and update business requirements,… 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 Position Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Individual contributor position, based in Plainsboro, NJ and reporting to the Manager , North America Operations - Infrastructure. This role is a ... About the Department The Finance and Operations dept. brings insights and intelligence to inform...cloud platforms are being used in a secure and quality -oriented manner. Solving ad-hoc technical challenges together with end-users… 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 ... difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific… 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 ... a primary point of contact for escalations related to quality of external data delivery. Identify ...developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data standards. Acts as a point of contact for escalations related to external data delivery quality . Ensures consistency in understanding and implementation of ... external data standards. Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings, and builds… more
- Merck & Co. (Rahway, NJ)
- …of low or non-performance.The role will work across the different country operations roles (eg CRM(Clinical Research Manager ), CRA(Clinical Research Associate)- ... with ICH/GCP and country regulations, company policies and procedures and-with quality standards internally and externally.Under the oversight of the CRD(Clinical… 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 ... define priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with publishing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are ... in database and research tools.ResponsibilitiesSupport the Head Global QA strategy and operations (RDPVMA QA)on projects needing to be coordinated with both DSI QA… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development ... and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, ... to Clinical Operations on site issues. Contributes to development of CSR. External collaboration: Consults with internal experts and external KOLs for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(GMP/ IMP QA, Audit Compliance, Quality Management System [QMS] QA, PV/MA Quality ) and in close collaboration with CAPA Manager .), on GxP topics/issues ... ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD business process… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, ... and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and-escalates per defined CRA Escalation Pathway… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager throughout all phases of ... and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation… more
