- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at… 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 ... Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …materials, POA timeframes and priority projectsProvide cross-functional support to Legal Operations as needed Partner with Regulatory Analyst on the submission of ... required Experience Qualifications4 or More Years experience in marketing/marketing operations and/or editorial function within the pharmaceutical industry or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management. Ability to work ... 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, ... 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.SummaryThe primary responsibilities of the Associate Director, Omni-Channel Marketing is to develop, plan and implement the ... as key inputs to decisions on business strategy given market dynamics. The Associate Director should support smooth execution of all omnichannel platforms, tools and… 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...seeks agreement through consensus management. Relationships Reports to an Associate Director / Director within the NNI Procurement Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the ... drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary:The Associate Director of Digital and Omnichannel Analytics Technology is responsible for ... cross-functional teams, including Omnichannel Center of Excellence, marketing, business operations and market access to implement data collection methodologies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team and Global Clinical leader to ensure effective team operations through meeting management, development plan/timeline management, scope management, stakeholder ... management, risk/issue management, finance and resource management, and conflict resolution. This position may be assigned to any therapeutic area and work on projects at any stage of development.As a member of the GMP&L function this position is also… 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)
- …role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound,...resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence to… 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...to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training materials and content on the speaker engagement platform.ResponsibilitiesProgram Operations :Lead the coordination of speaker bureau nomination process with ... Brand Team and co- promote partnersManage contracting process with Speaker Bureau vendor and co-promote partnersDevelop and lead Field training sessions - both live and virtualTrack speaker utilization and work with manager to escalate as needed.Coordinates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has ... experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and experience with regulatory submissions and inspections. Finally, this position has strong skills in continuous… more
