- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... Managers, Data Managers, Clinicians, vendors) to support the overall development strategyProficient in managing service agreements and vendor contracts.Where you… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... Job Description Job Description: - The drug development Project Manager is part of Global Project...of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical ... approved budgets.OR Functional Budget Planning - Manages and is accountable for the development and control of functional budget in support of global operations of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… 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)
- …diseases and immune disorders. Summary Responsible for managing the design, development , optimization and administration of global HCM Platforms and processes. This ... as a liaison between the customer community and the software development team, documenting functional, system, and process requirements.Possess a blended… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …objective setting sessions, Mid-Year Assessments, Year-End Assessments. Leads an employee development planning with each direct report. Sustains the payroll staff by ... recruiting, selecting, orienting, and training employees. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on ... Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case...strategies and activities for early and late phase drug development candidates within the team to support overall CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Business Process Manager, Global DX is responsible ... transformation and automation across the organization. Responsibilities Process Design, Development , and Optimization:- Coordinate and lead the conception, design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... (CSR): Leads statistical activities for complex studies including study design, protocol development , CRF review, SAP development , analysis files development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must ... include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Specialty Medicine Business Units and is responsible for executing business development opportunities across a range of categories designed to advance the ... require participation in supervising, training and developing entry-level business development professionals within the Global BD function (eg Fellow).Responsibilities-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& ManagementOversight of Data Request processing by Service ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and ... 8.0.x and 7.0.x Patches.Experience with SQL programming/querying, custom report design/ development from Argus Safety backend database.Strong knowledge of Oracle… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... collaboration with the Global Regulatory Lead(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. You… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …professional and personal development . Are you ready? The Position The Associate Director , Communication Ops is responsible for driving cohesive messaging ... overall success of the P&O function. Relationships This position reports to the Director of People Operations and sits within the larger Strategy & People Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... managed elsewhere internally or at vendors. Relationships Reports to the Senior Director , Advanced Analytics & Innovation. Works closely across the entire NNI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled ... delivery to their intended site of action.- The DPPD Team manages the development of the device constituent of our company's pipeline of combination products across… more
