- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in accordance with DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of...trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational… more
- Merck & Co. (Rahway, NJ)
- …alignment with the goals, purpose and mission of our Company Research Labs, Global Clinical Development (GCD) and GCTO.Ability to identify problems, conflicts ... Operations.Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to...and within budget to support drug development processes and global submissions. This position also partners with internal and… more
- Merck & Co. (Rahway, NJ)
- …forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...deep understanding of multi-modality composition of matter manufacturing, testing, quality and supply processes from late clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a project manager this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...project or be partnered with a more senior project manager in support of a larger, more complex drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... department, (subset of) NACD and/or as part of a global team and as aligned to a business case,...services/tasks in support of the planning and implementation of quality driven clinical trials, in line with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; ... department, (subset of) NACD and/or as part of a global team and as aligned to a business case,...services/tasks in support of the planning and execution of quality driven clinical trials in line with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …quality is maintained throughout the US supply chain Participates in various global product quality activities and projects Maintains up-to-date knowledge of ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Aequor (NJ)
- …planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4. The individual ... must partner closely with clinical , regulatory, quality and production associates to...Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... the Quality Unit and could include all or some aspects of the Quality function.The Product Development QA Manager provides quality focused customer… more
- Catalent (Manassas, VA)
- Site Procurement ManagerPosition Summary Catalent is a global , high-growth, public company, and a leading partner for the pharmaceutical industry in the development ... help create engaging new products consumers will love.The Site Procurement Manager is responsible for procurement leadership, sourcing and procuring materials,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), ... with the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , MSAT or ... in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role… more
