- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, Clinical Project & Planning Management is a member ... oversight and leadership across clinical programs/trials in areas of project management and planning, including related systems/tools, timelines, study metrics,… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Engineering Auto Eng ... position will report to the Director, Engineering, Automation Lead position and will be a member of the Auto Eng Team at the Rahway NJ facility. The Auto Eng Team is responsible for development of new technologies/capabilities, execution of capital and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life ... guidelines, and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. SummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence ... and adverse events related to our developing assets. This role requires project management skills to oversee this complex, cross-functional workstream and to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Direction, and Strategy:Provides medical coding expertise and guidance to the project team regarding the medical coding activities and deliverables. Ensures ... deliverables meet/exceed project /study team expectations regarding quality, time, and cost.Establishes medical coding strategy at the project and/or study level… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director, Field Medical Training will be responsible for the development, ... Workers requiring therapeutic knowledge of the Daiichi Sankyo portfolio. The Associate Director, Field Medical Training will have a variety of responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... 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. (Basking Ridge, NJ)
- …for patients who are likely to benefit from our therapeutics.ResponsibilitiesLeads CDx project teams for the diagnostic, in full alignment with Global Program Teams ... needs.Experience maintaining strategic direction while ensuring successful execution of project details.Solid interpersonal and verbal and written communication skills… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development, ... implementation of data standards practices within vendor relationships. - Project Management:Accountable for developing and promoting the strategy and infrastructure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial operations. Experience in training, process improvement, and project management a plus. required Experience QualificationsStrong experience and ... clinical research & development, clinical science, clinical quality assurance, project management) requiredStrong leadership, collaboration, influencing, and change management… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …may collaborate with team on CAPAs, including CAPA responses and approvals Project Management:Collaborates with the PSL(s) to proactively plan and prioritize safety ... communication skillsDemonstrated ability to handle more than one complex project simultaneously, prioritizing and recognizing key issues.Demonstrates effectiveness in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, ... with functional groups within Daiichi Sankyo, Inc. related to assigned products/ project areas such as the clinical supplies organization, Reg Operations, Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.SummaryThe primary responsibilities of the Associate Director, Omni-Channel Marketing is to develop, plan and implement the ... as key inputs to decisions on business strategy given market dynamics. The Associate Director should support smooth execution of all omnichannel platforms, tools and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to ... TA including at all PMRT meetings and through ad hoc meetings with project owners. Partner with colleagues responsible for PGC medical review to ensure seamless… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …handles sensitive documents that may impact multiple Global organizational units or Global project teams. The incumbent may be tasked under the direction of the ... Experience Qualifications- 7+ years of professional pharmaceutical experience in project management and operational support role and relevant additional career… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative ... to address prioritization across the portfolio within Oncology/Immuno-OncologyCollaborate with multidisciplinary project teams to develop and apply QSP models to aid… more
