- Merck & Co. (Rahway, NJ)
- …Division organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug Development ... the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams ... for partnering with the Global Team leader as the Project Management lead on drug development projects. This position...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Regulatory Affairs - Regulatory Project Management (RPM) provides ... regulatory project management activities without additional guidance. The Associate Director , RPM provides impactful contributions to the RPM group and the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC ... designed strategy, as well as developing activity plan, and budget for project . He/she (or subordinates) will lead cross-functional product decision and manage … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are met. Provides information to other internal departments where deemed appropriate.Develop project plans and manages the Year-End payroll project activities ... and approves the payment processing for each payroll. Establishes project plans and calendars for the payroll activities and...and maintain the PTO time interface to the RD Project Time system. Works closely with IT, HR, Equity,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... centered around rare diseases and immune disorders. Job Summary: The Director , Development SOP Management is responsible for providing strategic direction, planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary This position leads a team of Global Program & Project Managers for DX projects in specific areas such as Functional Units (R&D, Tech, ... Regional IT projects and optimized PM resource allocation.Responsibilities- Program and Project Delivery PgM/PM Assignment: Assign Program Managers (PgM) and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be defined based on the ... needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC...support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC Lead of an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project (s). Strategize and plan for FDA meetings.Serve as the primary ... breakthrough therapy designation requests, orphan drug applications.Participate in global project team meetings (development and/or marketed products); provide regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to ... Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Business Process Manager, Global DX is responsible for leading ... such as process automation, to achieve standardized process management Project Management and Strategic Implementation:- Manage global process projects and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. Conduct completeness, scientific accuracy, and ease of review of ... globally. Responsible for representing GRA in the GPT (Global Project Team) as well representing the project ...(Global Project Team) as well representing the project team in other DSI governance process (DRF, G-PAD,… more
- Merck & Co. (Rahway, NJ)
- …dedicated colleagues while developing and expanding your career. - The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and ... particular focus on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical development, including study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Enhance Demand management process in collaboration with DX Strategy and Project and Portfolio ManagementBRM best practices: Research the latest technology trends ... evaluate the success and impact of technology projects, collaborating with Project and Portfolio Management functionChange management support: Assist in change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have ... integration with existing applications / systems / platforms. Work with project teams to analyze solution requirements and produce preliminary solution design… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project (s).Strategize and plan for FDA meetings for assigned product. ... Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the full discussion for archiving. Serve as the primary contact with FDA.Lead and prepare FDA submissions, including but not limited to briefing documents,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all Strategic Sourcing efforts through to final contract, including project management, supply analysis, supplier identification, risk mitigation, sourcing ... by the Business and the utilization of suppliers.- Serve as the Project Management Owner for DSI's overall Supplier Relationship Management Program (SRM) with… more
