- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... for a living. Are you ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and CA supply operations including country… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for ... collaboration in cross-functional and multicultural settings including leading implementation of data standards practices within vendor relationships. - Project … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …best practices as well as strong technical skills in working with (clinical) data . The position holder will require strong skills in continuous improvement, ... project management, change management and risk management.Responsibilities ...and translation of business needs to AI/ML tasks, over data understanding and preparation, to modeling, validation and dissemination-… 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 ... 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)
- …of Phase 1 studies and multiple dose scenarios, PK/PD M&S analysis data structures and analysis tools requirements, simple disease models, regulatory guidelines ... This position works independently in simpler studies/models and interacts with internal project teams. Responsibilities Analyzes and presents MS Analyses of Phase 1… 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 ... content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate- In collaboration with Head, Global QA Strategy and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meet business goals, including change management and implementation planning, for GOCD non- project related initiatives. The Associate Director , GOCD ... through monitoring and oversight of shared e-workspace. (eg, Teams sites, SharePoint).Additional non- Project related activities: The Associate Director , GOCD… 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 ... Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ownership of their learning plans. The ideal candidate will be creative, data driven, and learner-obsessed with experience in developing and managing a learning ... whether desired learning and performance outcomes are achieved.- Manage project timelines and coordinate appropriate internal resources to create high-quality,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... to address prioritization across the portfolio within Oncology/Immuno-OncologyCollaborate with multidisciplinary project teams to develop and apply QSP models to aid… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Strategy:Provides data management (DM) expertise and guidance to the project team regarding the data management DM activities and deliverablesEstablishes ... Data Management strategy at the project and/or study level for a larger number of...data management deliverables for all studies within the project /program level meets quality , time and cost effectiveLeads… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …excellence in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex ... procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of ...Data Analysis Based Decision-Making- Uses rigorous analyses of data as well as market supply base information for… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will ... and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the assets are easily accessible and properly utilized. Relationships Reports to the Associate Director of Content Management; Provides direct support to the ... or service feature additions that would favorably impact key metrics Strong project management, problem solving and analytical thinking skills Requires knowledge of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …platform provides a seamless user experience for customers. Relationships Reports to the Associate Director of Content Management; Provides direct support to the ... or service feature additions that would favorably impact key metrics Strong project management, problem solving and analytical thinking skills Requires knowledge of… more
