- Tris Pharma (Monmouth Junction, NJ)
- Sr Project Manager , Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, ... timing + roles + responsibilities for prgms incl scale-up activities, process validation, post-validation changes + comm w/ FDA. Provide tech spt to manufacturing + packaging ops or other depts by leading proj w/ organizing interexperiment teams + driving… 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 ... existing systems in Regulatory AffairsRequired Skills5 years of Regulatory Operations experienceExtensive knowledge and experience with Microsoft Office, Adobe… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …batch records, forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, ... treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor (2nd shift) as part of the Technical... Supervisor (2nd shift) as part of the Technical Operations team based in Raritan, NJ. Role Overview The… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and workstream implementations for effectiveness.-monitor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global ... clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS) Support the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL ... and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working ... on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas. Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …maintaining innovative technology solutions for Meetings and Events, ensure smooth operations , and collaborating with vendors to optimize services and achieve ... successful outcomes. The role will oversee M&E vendor training programs and initiatives. The role will be crucial to enhancing participant experiences, streamlining processes, and driving excellence in meeting execution.Responsibilities Meeting and Event… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... of External Vendors by engaging with key cross-functional stakeholders (Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing data collection, data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The primary responsibilities of the Manager , Omnichannel Marketing is to support the development, planning and implementation ... customer segments across the portfolio in partnership with brand teams. The Manager should assess external digital opportunities and threats, customer journeys, and… 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 ... as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the established RD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... including data standardization, natural language processing o Data Quality operations that standardize data definitions, implements quality rules, and aligns… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and qualification and Computer Software Assurance (CSA), SDLC related to pharmaceutical operations . required- 1 or More Years Direct dealings with FDA, EMA, PMRA, ... appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors is preferred. preferred- International… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ownership to position & deliver upon near & mid-term NACO ... studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide...maximize your potential with us? The Position The Product Manager is driven by a customer-centric mindset to meet… 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 ... & Marketing Enablement functions (Omnichannel Engagement, Field Systems, Marketing Operations ) and other NNI functions (Marketing, Advanced Analytics, IT) to… more
