- 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
- Merck & Co. (Rahway, NJ)
- …to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The ... planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of...of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and… 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)
- …Oncology department of the Global Precision Medicine function. The Manager , CDx Diagnostics Scientist's primary responsibilities are:Assists in defining the ... at central and analytical labs for clinical trials. Supports the development and implementation of standardized template requisition forms, scoring forms, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Safety Scientist Product Lead and PSL.May serve as a project manager for other activities involving assigned product(s) or clinical studies, as ... preferredPhD preferredExperience QualificationsPossesses scientific or therapeutic area and drug development knowledge (preferred).0-1 year of experience with an advanced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Safety Scientist Product Lead and PSL.May serve as a project manager for other activities involving assigned product(s) or clinical studies, as ... preferredPhD preferredExperience Qualifications:Possesses scientific or therapeutic area and drug development knowledge preferred0-1 year of experience with an advanced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Safety Scientist Product Lead and PSLMay serve as a project manager for other activities involving assigned product(s) or clinical studies, as ... preferredPhD preferredExperience QualificationsPossesses scientific or therapeutic area, and drug development knowledge preferred0-1 year of experience with an advanced… 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)
- …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)
- …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)
- …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
- Tris Pharma (Monmouth Junction, NJ)
- …privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet patient needs. ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
