- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensuring global DBMA quality standards for Change requests- IT Vendor Oversight and Management . Managing CSPV IT Budget for Local DSI CSPV Systems ... data requests, perform self-QC of data to ensure quality of results.- Service Provider Oversight and Management : Oversight of Data Request… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … data management background and strong knowledge of 3rd party vendor management and oversight of external data standards. Knowledge of CDISC and ... rare diseases and immune disorders. Summary The Manager External Data Management , is accountable for an end-to-end...data exchange processes. Assist with review of External Data quality checks, External Data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts ... Partner Management responsibilities.ResponsibilitiesPV Agreements and Contracts:Leads PVA/SDEA Management and maintains oversight of PV relevant contracts.… more
- Merck & Co. (Rahway, NJ)
- …executing objectives setting, mid-year and year-end reviews, etc.).Accountable for the CTLs oversight involving samples management / testing of products with the ... permanent inspections readiness, regulatory inspection support and monitoring, change control oversight and management , metric review, and review of annual… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management ... on deviations and PQC investigations relating to production operations, quality operations oversight and quality ... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks… more
- Aequor (West Greenwich, RI)
- …experience in detail during the interview.Responsibilities: Primary focus is the support and oversight of 's Quality Management Systems ensuring key ... is the working environment for this role? Role supports quality management systems, office based, EW will...for assigned plant(s) or functional area(s) Responsible for providing Quality oversight to ensure that 's systems… more
- Merck & Co. (Durham, NC)
- …validation activities, including latest trends in validation and best practices. Represent Digital & Data Quality management upon request in local site or ... Manual or with potential for impact on product quality , patient safety or data integrity. Work...operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle… more
- Aequor (West Greenwich, RI)
- … quality requirements and deviations. Responsibilities Include the Following: Provide Quality oversight to ensure that operations products are manufactured, ... accurate, and documented according to written procedures and cGMP requirements. Alert management of quality , compliance, supply and safety risks. Complete… more
- Eisai, Inc (Nutley, NJ)
- …and regional teams on information security and protection, as well as data privacy initiatives.This role involves substantial global management across Tokyo, ... want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio of IT Compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position This position is responsible for the financial management and oversight of internal and external strategic collaborations to ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team GLLs and to cross-functional labeling review team members. Responsible for the broad oversight of Core Data Sheets and US/EU label changes for products in ... review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Oversight : Provides effective and timely safety updates to management on matters concerning safety promotional review, safety labelling committee input, ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....safety data analysis and contract review and vendor … more
- Merck & Co. (Rahway, NJ)
- …of our Company 's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational ... Sciences & Clinical Supply. The ideal candidate should have strong project management skills and a demonstrated commitment to operational excellence, with an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as budget review and forecasting Independently manage interactions with clinical monitors, data management , safety, regulatory and QA team members, both ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...will be responsible for all aspects of clinical project management for a trial(s) in our portfolio which includes… more
- Insmed Incorporated (San Diego, CA)
- …individual will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies, review & ... interpretation of clinical trial data , authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data .… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Statement of Works (SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR Organization. Additional ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within facilityPerform internal housekeeping auditsPerform analysis on quality indicating data and identifying trendsProvide oversight for trending of ... Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …appropriately tracked, archived, searchable and accessible Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …can be deployed in different scenarios); hands-on experience using social media management tools Cross-functional editorial oversight and project management , ... and enhance and protect NNI's corporate reputation through digital community management and engagement. The Associate Director, Digital Content Strategy & Production… more
- Merck & Co. (Millsboro, DE)
- …compliance with all federal and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP ... the role of Associate Director.This position will have overall responsibility for oversight and administration of day-to-day operation of the animal facilities as… more
