- Legend Biotech USA, Inc. (Piscataway, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a CAR-T Warehouse Operations Associate as part of the Technical Operations team based ... in Piscataway, NJ. The CAR-T Warehouse Operations Associate will be part of the Technical Operations team responsible for the production of a personalized… more
- 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
- 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)
- …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
- 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 ... the treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor / Sr. Operations Supervisor (2nd shift) as part of the Technical … 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 ... a variety of tasks and projects related to tax operations and ensure the delivery of high-quality work products...company's compliance with these laws.Training and leading the tax operations team, overseeing their work, and providing guidance when… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and ... guidelines, and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation… 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
- 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)
- …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)
- …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
- 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)
- …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
- 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)
- …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)
- …is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. Responsibilities:Study ... Planning and Execution:Develop project cross-functional, integrated study plan to study start up (in-house) and validate and manage to the overall study plan provided by the CRO. Participate in site selection and site qualification with (study team and… 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
