- Merck & Co. (Rahway, NJ)
- …Division portfolio of clinical trial s .- GCS is accountable for the planning , sourcing, labeling, packaging and delivery of clinical supplies to clinical sites ... globally. The GCS Planning ( Planning ) organization is the key interface...the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS… more
- Merck & Co. (Rahway, NJ)
- …Laboratories portfolio of clinical trial s .- GCS is accountable for the planning , sourcing, labeling, packaging and delivery of clinical supplies to clinical sites ... globally. The GCS Planning ( Planning ) organization is the key interface...- - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or Pharmaceutical industry10 or More Years Demonstrated success as a project manager /leader in planning and executing strategies for global drug development: ... maintaining a high performing team.Generate critical path analyses and lead scenario planning with GPT to select best option understanding cost and timeline… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role in a biotech or pharmaceutical company.Demonstrated success as a project manager /leader in planning and executing strategies for global drug development, ... the project environment to address gaps that impact the program/project.Manages the planning and use of program/project resources and works to secure adequate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SDV plan. Performs literature review and creates reference list for study.Study Planning : Contributes to clinical trial planning including identification of ... potential risks to study deliverables; development of contingency plan; development of protocol profile, protocol, and ICF template; selection of ARO, CRO, and members for DSMB and/or adjudication committee; development of charters for study committees (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Manager , US Marketing will be responsible for supporting key work streams in ... functions involved in the execution of the annual brand planning process and key marketing initiatives. The position maintains...success of product messaging, programs and promotional effort. The Manager is also responsible for working on a broad… 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 ... has a high level of supervision and is supportive in nature.Responsibilities: Planning for Development and Post Marketing Projects: Manages CMC development and post… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drug product release programs in accordance with internal procedures. Support proactive planning and forecasting for commercial and IMP relevant activities and QA ... provide product quality/GMP support for timely activities related with the release, planning and supply forecast of commercial and IMP drug product. Supports… 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 ... expert and provide oversight and technical support in the planning , setup, and application of security and access models...for clinical data in CDR. Contribute to designing and planning the foundational capabilities for the new CDR versions/system… 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)
- …the creation of SOP's and work instructions specific to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related ... Management, and/or Pharmaceutical Development. preferredOncology experience preferredCreation of Supply Planning tools preferredAbility to travel up to 10% Overnight… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Manager of External Brand & Content Strategy will be instrumental in shaping ... and lead editorial and production for that content. Event Curation and Planning : Plan impactful, creative bespoke events (often with corporate partners) catered to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... and impact assessment of new regulatory issues and the planning of audit timing and milestones. Leads cross functional...inputs and guidance to line of business and Financial Planning and Analysis team during the anchor budget and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance Manager ... resources and information from established internal contacts; consult with manager for decisions outside established processes.Routinely recognize and resolve… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …data driven improvements to improve program offerings Support the annual brand planning process with data driven insights Support Execution of ongoing analyses of ... the market in terms of coverage and reimbursement issues impacting Novo Nordisk's products, existing and emerging payer policies, competitive reimbursement landscape, trends, pricing, contracting strategies and potential barriers to provider and patient access… more
- Genmab (Plainsboro, NJ)
- …Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical ... Drug Supply Manager you will play a pivotal role in ensuring...supplies, collaborating closely with the Global Clinical Drug Supply Planning team. Together with the Global Clinical Drug Supply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible ... milestones and objectives on time and on budgetDrives milestone decision point planning and associated deliverables across functions to achieve the overall project… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.Brand Finance Manager , US MarketThe Brand Finance Manager will play a critical role in ... to drive growth and ensure financial goals are met. TheBrand Finance Manager is responsible for supporting all aspects of brand financialperformance, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …highest standards of scientific rigor and ethics. The Senior Global Medical Manager will drive and collaborate with cross-functional teams to develop, implement, and ... professionals though robust medical education initiatives. The Senior Global Medical Manager will leverage data-driven insights and foster strong relationships with… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... technical responsibility (minimum 3 of those years in a supervisory or manager role) Special knowledge or skills needed and/or licenses or certificates… more
