- Merck & Co. (Rahway, NJ)
- …and Development (SMAR&D) group has an exciting opportunity for a director role as Strategic Operations Lead based in Rahway, NJ. As the Strategic Operations ... strategic partnering with Development Quality, Process Research & Development, Pharmaceutical Operations , and other parts of the AR&D organization to deliver on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi ... clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, on regular basis and ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for ... at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of ... Management -supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift ... Legend Biotech is seeking Operations Supervisor as part of the Technical ...team-based environment, on an assigned production shift schedule.Key Responsibilities Lead and supervise multiple units within the CAR-T process… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… more
- Merck & Co. (Rahway, NJ)
- …SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw ... process development, and seamless technology transfer to commercial sites.The SSO Operations Specialist will provide hands on assistance for daily production… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and reporting under RBQM Central Statistical Monitoring ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAccountable to lead , manage and ensure that all Contract Manufacturing, Testing and Warehousing ... which include API and drug product manufacturing, packaging and labelling operations , QC testing and release, and distribution for biologics and small-molecules… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …attorney and lead legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products.Acts as legal advisor ... the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology...Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk ... functions, eg Clinical Development, Medical Affairs, Regulatory Affairs, Clinical Operations . Formulates strategic approaches for risk mitigation for global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and prioritize improvement opportunities with the greatest impact.Process Optimization Lead initiatives to standardize, simplify, and optimize core processes across ... to articulate the value and progress of continuous improvement efforts.Team Leadership Lead , mentor, and develop a team of Continuous Improvement professionals to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. ... labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leverage new and existing internal opportunity management tools to support the operations of the SE organization as it relates to tracking incoming ... generally accepted BD practices. preferredDemonstrated project management/leadership skills to lead /manage cross-functional teams in evaluating target opportunities partnering opportunities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or other external process steps where appropriate.Ensure and execute smooth operations and technical support of the relevant HRIS Module(s) including technical ... and support materials for end-users, handling of queries, troubleshooting, and quality control. Lead or support consulting and implementation projects in the area of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead ... Director of Manufacturing Excellence by providing technical expertise to Technical Operations and ensure safe and compliant manufacturing operations according… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Cleaning Validation Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Cleaning Validation Lead ... following necessary FDA / Annex 1 requirements. This person will be the lead for cleaning validation program, working cross functionally with various departments to… more
