- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is responsible for ... but not limited to, original INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory Operations in developing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations on ... management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular ... file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the assigned… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part of ... the Technical Operations team based in Raritan, New Jersey. Role Overview...This individual is required to manage a global strategic operations to ensure that available and future capacity can… more
- Eisai, Inc (Nutley, NJ)
- …support of operational and business matters. This role will report into the Director , Government Pricing and Contract Operations and collaborate across all ... functions. Essential Functions Lead the Contract Operations team ensuring timely and accurate review and processing of claims.Serve as a subject matter expert… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life ... and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & ... oversight standard practices across GCO and work with Global Clinical Operations , as needed, to understand business priorities.Develop and establish more streamlined… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to collaborate with, and support the head of Global QA strategy and operations . In this position, the incumbent will take on organizational responsibilities relevant ... tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA,...and allow decision making.Responsibilities- Support Head, Global strategy and operations on projects needing to be coordinated with both… more
- Merck & Co. (Rahway, NJ)
- …Tax We are seeking an experienced tax professional to join our team as an Associate Director of Tax Operations .The Associate Director of Tax Operations ... will report to the Director of Tax Operations and will work closely with various internal departments,...a variety of tasks and projects related to tax operations and ensure the delivery of high-quality work products… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in a global matrix of biomarker and translational scientists and clinical operations . The candidate must have effective project management skills and communicate ... Translational Scientists, Companion Diagnostic Scientists and Clinical Scientists and Operations Leads in the review of clinical protocols, laboratory instructions,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and provides written assessments of relevant medical topics, and supports PV Operations ' medical review function. This position supports a senior physician in ... evaluating and mitigating safety signals as they arise. Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single event level AE causality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and other internal groups) and ... outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication with clinical sites in collaboration with clinical development staff.Consults with KEE's for advice on complex patient safety issues.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This role ... of experience required Experience Qualifications.7 or More Years 7 years clinical operations experience in trial diversity and patient access and/or clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …roles in Global DX / GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption of metrics. Act as a Liaison between ... MARS and RD Line Functions for promotion of Metrics and Dashboards strategy.Team Management Manage the Metrics Business Analyst Team Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure sucessful implementation ... of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyCreates a forward-looking Diagnostic development strategy while keeping… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.SummaryThe primary responsibilities of the Associate Director , Omni-Channel Marketing is to develop, plan and implement the ... inputs to decisions on business strategy given market dynamics. The Associate Director should support smooth execution of all omnichannel platforms, tools and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and ... assigned products/project areas such as the clinical supplies organization, Reg Operations , Medical Affairs and labelling.- Participates in meetings with Health… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be responsible for lifecycle ... 10 years' experience in pharmaceutical or biotechnology across clinical trial operations . Experience in training, process improvement, and project management a plus.… more
