- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … stewardship and governance processes, data cataloging data standards, data quality, and data management .- Develop and implement strategies for ... cleansing and standardizing data , with a focus on eg, clinical, product...program, data stewardship program or similar intent data management program focused on setting standards,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead ... is responsible for the management of technology transfer of the manufacturing processes of...of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial drugs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a ... in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Preferred Knowledge of Pharmaceutical Data like IQVIA, Veeva, Customer or Product Master Systems Knowledge of Snowflake Database, Tableau, QlikSense and ... solutions Specific or technical job skills: Experience in solution design, data management , data integration and database development techniques. Works in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ADaM data set specifications, reviewer's guides, etc. - Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST and DSE to… more
- 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 ... of a One Impact Planning strategy to optimize the therapeutic area product portfolio, aligning with the overarching corporate goals and market dynamics. Ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of diagnostic or precision health products including project planning and product management activities. Support implementation by educating stakeholders on ... holistic approach to diagnostics in support of the customer journey Portfolio Management : Oversee the diagnostics health portfolio, including product lifecycle… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... 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)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population...Phase 3 registrational study(ies); Develop prospective contingency plans for management of key risks in a large study or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST and DSE to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... make a difference? The Position To ensure oversight and management of all contract and vendor related activities in...Master File (PSMF). Ensures accuracy and completeness of data collection programs and associated SDEAs in the Global… more
- 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 ... phasing of objectives based on engagement objectives and sales forecasts Brand Management : Develop brand persona, messaging and concepts inclusive of the positioning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality risk management process. Interact with the audit function. The respective Data Management groups and respective CROs in order to ensure high ... business setups with the objective of achieving the highest data quality standards, full adherence to patient's rights and...Head of RD QA with Quality Reviews of respective product profile to ensure appropriate management review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other data sources to contextualize safety events for assigned product . Research natural history of disease to characterize background event ratesDesign and ... of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries out… more
- Lundbeck (Philadelphia, PA)
- …of account-specific strategies that improves customer engagement and account management throughout the patient journey, focusing on improved customer experience ... plans for internal stakeholders incorporating customer and market insights to make data driven decisions; demonstrating executive level interpretation of data to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …portfolio plus emerging pipeline assets) and key functions.- Contribute to data generation proposals and decision-making that optimizes Daiichi Sankyo's presence in ... on customer insights, external landscape, and internal information including overall product development plans.- Proactive planning for asset milestones to account… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …portfolio plus emerging pipeline assets) and key functions.- Contribute to data generation proposals and decision-making that optimizes Daiichi Sankyo's presence in ... on customer insights, external landscape, and internal information including overall product development plans.- Proactive planning for asset milestones to account… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on ... and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , authoring CMC submissions, and interacting with Health Authorities to meet… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We ... @JazzPharma on Twitter. The Director will be responsible for managing the product leaders and external FSP personnel, overseeing all ongoing clinical studies, and… more
- EY (Philadelphia, PA)
- …consulting, advisory, cybersecurity assessment, or auditing. Alternatively, will accept a Master 's degree in Management Information Systems (MIS), Computer ... support, and training. - Security and Privacy Information Systems assessments, data analysis, design, architecture, implementation, management , and reporting. -… more
