- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for representing the GCO-CQM inspection ... research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. SummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence ... strong presentation skills and be comfortable interacting with many different global functional groups, external vendors, as well as leaders.Responsibilities-… more
- 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 ... 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
- 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)
- …regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the ... in the strategic planning for future change. Subject matter expert on global clinical trial registration, result posting, plain language summary, redaction… 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
- Merck & Co. (Rahway, NJ)
- …intellectually curious, join us-and start making your impact today.- - Overview:- - - Global Clinical Trail Operations (GCTO) is a global organization with ... responsible and accountable for the execution of the Merck clinical research portfolio. The Global Clinical...activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical … more
- Merck & Co. (Rahway, NJ)
- …the availability of clinical supplies for patients. Within the PSCS team is the Global Clinical Supply team located in Rahway (NJ), and West Point (PA). The ... is responsible for translating a therapeutic agent into a functional drug product optimized for patients and for ensuring...team environment to help solve key challenges in the clinical supply chain.--The Global Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …according to the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...in accordance with DS standards. Act as the project manager of the clinical study team to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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
- Merck & Co. (Rahway, NJ)
- …the intellectually curious, join us-and start making your impact today. -Overview: Global Project and Alliance Management (GPAM) sits in the research & development ... discovery, development, and alliance teams at Merck. Project Managers drive these cross- functional teams to deliver projects and products that improve human health… 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
- Merck & Co. (Rahway, NJ)
- …are among the intellectually curious, join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global organization ... technical skills, and scientific acumen as part of a global , cross- functional team. Primary responsibilities include the...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . --Your… 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
- 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)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Merck & Co. (Rahway, NJ)
- …are among the intellectually curious, join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global organization ... your leadership and technical skills as part of a global , cross- functional team. You will apply project...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …communication and coordination. This position collaborates within global CSPV and cross- functional teams. As a project manager this position is responsible ... Responsible for planning, managing, and coordinating projects within DSI CSPV and global clinical safety and epidemiology function. Deliver the project according… more
