- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study (-ies) utilizing Microsoft Project or equivalent.Lead the creation of the cross- functional Clinical Study Oversight Plan (CSOP) under the guidance of the ... Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction...The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Manager , Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global ... Management within the Global Data Management & Standards (GDMS) organization, the Manager Global Data Standards - Ops and Reference Data Management is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution ... review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of...study activities with other relevant GOMA functions and the Global Medical Affairs Team. Regional and Functional … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...support and may manage day to day functional excellence activities to include, but not limited to,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross- functional team(s) in support of benefit risk ... with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross- functional team(s) in support of benefit risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is filed/archived according to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, ... 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)
- …Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... teams and senior leaders from across Regulatory Affairs, as well as cross- functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations,… 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. ... Global Team Leaders.Responsibilities- Creating and leading a high performing, cross- functional global project team composed of representative of asset… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... The Position Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies within the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resourcing and budget alignment in close collaboration with finance and functional team members.Maintains global integrated project plans, project timelines, ... role in a biotech or pharmaceutical companyDemonstrated success as a project manager /leader in planning and executing strategies for global drug development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ensure in collaboration with Global Development Operations ... (GDO) ( Global Clinical Operations / Clinical Quality Management or other RD business process owners that applicable clinical development processes and… 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 ... project or be partnered with a more senior project manager in support of a larger, more complex drug...complex or regional projects (within the scope of the Global Development Process and Functional Procedures) or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, ... 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
- Aequor (NJ)
- …Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all ... 100 % remote Manager prefers local candidates (will consider non local...cross- functional teams. Proactively defining, planning, and communicating clinical supply strategy in support of global … more
- Integrated Resources, Inc (Foster City, CA)
- …contracting expertise in clinical outsourcing of global Phase 1b-Phase 3 clinical trials. The Sr. Manager will lead the entire life cycle including ... Client is currently seeking an industry leader for Sr. Manager , R&D Outsourcing within our Development Business Operations department....but is not limited to: Delivery Excellence * Develops global clinical development vendor strategy for a… more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to ... remote, travel to HQ for one week every quarter is required**Arthrex is a global medical device company and leader in research, new product development and medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical ... reviews and MSA discussions of External Vendors by engaging with key cross- functional stakeholders ( Clinical Operations, Clinical Biomarkers, QCP, etc.)… more
- Eisai, Inc (NJ)
- … areas to obtain all applicable source materialCollaborate with cross functional teams like Clinical Research, Biostatistics, Statistical programming, Clin ... want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical...incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of 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 ... as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
