- Merck & Co. (Rahway, NJ)
- …the 'end-to-end' integrated clinical supply chain across the full our Research & Development Division portfolio of clinical trial s .- GCS is accountable for the ... The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.-- - - The… more
- Merck & Co. (Rahway, NJ)
- …The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.-- - - ... Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans...and serve s as the GCS spokesperson at clinical development related meetings (i .e., Clinical Trial Team s… more
- Formation Bio (New York, NY)
- …and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating more candidate drugs ... cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new...to patients faster and more efficiently.About the PositionThe Senior Manager of External Brand & Content Strategy will be… more
- Formation Bio (New York, NY)
- …and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating more candidate drugs ... cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new...and more efficiently. About the PositionAs a Lead Product Manager , you will help execute on our tech strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: Drafts development plans, protocol profile, protocol, and clinical sections of submission documents ... under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs Labeling position will provide Regulatory support for global ... labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support to the BPQLs and GQLs by reviewing and providing input during the development and implementation of Protocol (study level) and Global and Local policies and ... with oversight by RD Quality team members, during the development and execution of Corrective and Preventive Actions (CAPAs)...to gather and generate the data required for the development of relevant quality reports and outputs (JOC, QRB,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …IB, NDA, Amendments, Supplements, Briefing Books) for review by higher-level manager . This position demonstrates understanding of key regulatory guidances and their ... application during the development process. Additionally, this position interacts with the Contract...in preparation of submission documents for review by higher-level manager . FDA Interactions: Leads FDA interactions with high level… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management of product release programs, deviation investigation programs, standards development and training activities, and supporting complaint and recall ... with internal and external stakeholders to complete deviations in a timely manner. Development and Review of Standards and Procedures (SOPs) and Training Activities:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... Generative AI solutions that align with their needs. Drive the research, development , and implementation of generative AI models and algorithms, ensuring they meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills and is able to work in complex categories. Assist in the development and implementation of new processes, procedures and/or systems to improve organizational ... master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and approval in accordance with company policies.-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and ... to internal audits and health authority inspections. Contribute to the development , maturity, and consistent application of external data vendor access standards… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes creation of master label text, translations, and ... experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferredOncology experience preferredCreation of Supply Planning tools preferredAbility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Sr Director GPM&L is accountable for delivering an integrated drug development strategy and tactical plan including options analysis of team's proposals in ... and decision making.Responsibilities: Project ResponsibilitiesIndependently manage or lead strategy development for high complexity drug development projects/programs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development ... partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be assigned to any therapeutic area and work on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... and regulatory compliance, lobbying activities, political contributions, public policy development , and state and federal compliance. Develops contract templates,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the strategic oversight, planning, and execution of all non-regulated systems development and implementation within the organization. This role ensures that all ... and best practices. Stay abreast of emerging technologies and trends in the application development and integration areas to ensure delivery of the most up to date… more
