- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- ... statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and… more
- Taiho Oncology (FL)
- Sr. Manager , Medical Field Florida, USA Virtual Req #442 Sunday, February 23, 2025 Looking for a chance to make a real difference in the oncology space? Taiho ... known as Medical Science Liaison Position Summary: The Sr. Manager , Medical Field is a field-facing representative of the...Field is a field-facing representative of the Medical Affairs Department with a primary responsibility to engage in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
- Eisai, Inc (Exton, PA)
- …and documentation overhead while maintaining the intended level of controls. The Senior Manager is responsible for supporting quality awareness efforts to ensure ... for internal and external computing platforms and solutions.Conducts audits and periodic review as assigned for quality assurance compliance with regulations and… more
- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization.- Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and accountable… more
- Merck & Co. (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... supplies.-Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution.Leads all aspects of strategic sourcing to ensure best value (cost, quality , Account Mgmt, timelines) for the businesses. Performs in-depth bid analysis ... involves working with suppliers and internal stakeholders to define scope and review of work orders and agreements. Mitigates supplier issues and develops action… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision ... of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires...quality /performance and budget, resources and timelines across the department and ensures timely delivery of high- quality … more
- Novo Nordisk Inc. (Durham, NC)
- …(CR's) related to revalidation & other validation activities for AP Author & review validation procedures, specifications & quality documents for accuracy & ... About the Department For more than 100 years, Novo Nordisk...in pharmaceutical or medical device industry required Experience in quality concepts including technical & compliance review … more
- Aequor (Swiftwater, MN)
- …ability to work in a team environment, effectively interacting with others. Review current documents- incorporate comments from Manager . Navigate through Content ... change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to...Incorporate comments from team members and provide status to manager on review and approval workflow. Follow… more
