- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This...and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Provide support ... for all aspects of Global Clinical Operations with a high degree of quality in...and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary The ... Biosample Operations Manager , Biosample Management is responsible for supporting the oversight...lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummarySupport the PVQA ... interventional, non-interventional, investigator-initiated trials, Managed Access programs and Collaborative Research to the highest quality standards globally end-to-end end… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryAs a ... Manager , Generative AI, you will be responsible for conceptualizing,...AI solutions that align with their needs. Drive the research , development, and implementation of generative AI models and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position is ... the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Manager ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...§ 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Manager , ... coaching for progressive skills development; Assessing and training product knowledge and clinical selling; Teaching and coaching managed care overview, as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary:Accountable to ... commercial and IMP as a result of distribution practices, manufacturing sites, clinical sites and testing laboratories and assures they are documented and resolved… more
- Merck & Co. (Rahway, NJ)
- … Clinical strategies.- Position Description/Summary: The Senior Specialist, Project Manager , is a core member of Development and Commercialization Teams (DCTs), ... Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development Division at our company. The Project Managers in GPAM are core… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT...the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary NOTE: This ... Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling...position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThis position is ... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing Clinical Sub-team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Job Summary: This position ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Merck & Co. (Rahway, NJ)
- …testing new systems, and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, ... At our company, we're shaping the future of health. We're seeking a Clinical Database Developer who will be instrumental in creating and developing clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Reviews and ... career, of direct reports, and mentors or acts as functional manager of staff resides in other offices as needed.Responsibilities:Protocol Development, Statistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads ... Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads ... address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal… more
