- Merck & Co. (North Wales, PA)
- … studies.-Under the direction of the Program Lead, you will collaborate with global , cross- functional team-members including clinical directors and study ... the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study… more
- 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)
- …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)
- …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)
- …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)
- …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)
- …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. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization ... of our company.- Position Description/Summary: The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late Drug Development… 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)
- …a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development and management of other ad hoc special projects as ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …through regularly scheduled 1:1 meetingsCollaborate with Clinical Study Manager on SA deliverablesParticipates in departmental and cross- functional process ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Manager , Study Associates will ensure the SAs provide clinical administrative support to the study teams and support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle ... with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the curriculum in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related areas (eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end ... 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)
- …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
- 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 ... product quality, integrity and compliance with regulatory guidelines and internal/ global standards and procedures. Responsible for managing activities within 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)
- …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 ... other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject… more
