- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …diverse talent and benefit from a range of possibilities for professional and personal development . Are you ready? The Position As Manager of Academy and ... Human Resources, and Legal, Ethics & Compliance around learning and development needs. External relationships may include interaction with various outside partners… 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
- 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
- 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
- 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... Accounting at Novo Nordisk Inc. As part of the NNI Finance team, the manager will business partner with budget controllers (FP&A) and other key stakeholders across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …fully integrated into strategic initiatives including those related to business development activities and enterprise initiatives. This role ensures alignment across ... globally, and leaders across lines of business. Works closely with Business Development colleagues and/or commercial colleagues working on new enterprise to provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... the company's patient support objectives for inline and launching brands Support the development and maintenance of SOPs and business rules related to all US patient… more
