- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... guide the successful completion of promotional initiatives. Relationships Reports to Director , Marketing Operations. Primary interaction is with teams that submit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operations, marketing and compliance. Relationships This role reports to the Associate Director -Patient CRM Product Owner. Collaborates cross-functionally with ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and ... areas/ SAP Finance modules: Asset Management, General Ledger, Travel Management, Master Data , Procure to Pay, Invoice to Pay, Project Systems, Taxes, Vertex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , authoring CMC submissions, and interacting with Health Authorities to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Development on Project Teams. Responsibilities Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development ... cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo...execute experiments, document, and interpret scientific results, present the data to cross-functional teamsIn vivo study design and assay… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across...either the US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in class sourcing and procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of data as well as ... knowledge of clinical trials preferred- Demonstrated ability to leverage digital data and analytics preferred- Demonstrated ability driving or participating in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides ... input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with internal ... statistical programmer.Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... reuse. Maintains detailed Solution Architecture diagrams for ALL systems, integrations, and data flows. Work with the Enterprise Architecture team to ensure all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the category strategies. Proactively uncovers insights and value from all Category data to identify new areas of opportunity for additional sourcing value and ... helps influence and inform budgeting decisions by the Business and the utilization of suppliers.- Serve as the Project Management Owner for DSI's overall Supplier Relationship Management Program (SRM) with Tier 1 suppliers which includes robust comprehensive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Review and interpret regulatory guidelinesContinuing Education: ... Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. Qualifications: Successful candidates will be able to meet the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that knowledge preferredTechnical knowledge of modeling tools (eg Excel) and data sources (eg Symphony, IQVIA) preferredSufficient understanding of financial matters ... to challenge and pressure-test assumptions (eg pricing, GTN, etc) preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on publication planning and execution ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Genmab (Plainsboro, NJ)
- …our purpose. We are looking for a highly motivated and collaborative Associate Director , Medical Writing. This is and individual contributor/technical position, ... not people-management position. As Associate Director , Medical Writing, you will serve...are not limited to, medical, statistics, programming, trial management, data management, regulatory, nonclinical, CMC, and project management. The… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose. The Role and Department The Associate Director will develop and maintain relationships with select clinical ... internal and external stakeholders (eg, Medical Affairs, Quality, Medical, CRO), the Associate Director Site Alliances role will bring a strategic, high-touch… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose. The ( Associate ) Director of Biostatistics acts as a statistical expert supporting the ... and/or as trial responsible statistician with responsibilities as described below. The ( Associate ) Director chips into clinical development strategies and plans.… more
- Genmab (Plainsboro, NJ)
- …assigned Genmab products (mainly investigational) throughout their lifecycle. As our Associate Director , you must effectively interact cross-functionally at all ... will interact with stakeholders ranging from regulatory authorities and Data Monitoring Committees as well as colleagues from other...as well as colleagues from other Genmab sites. As Associate Director , GDS&PV Physician, you will be… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products. The Solution Architect will… more
