- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support the Company's vision including elements to achieve a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. ... functions globally and with external parties as required.Champions 'Quality by Design ' and Quality Risk Management approaches to quality management within Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Job SummaryThis role is responsible for design and overseeing, coordinating, and managing activities related to the ongoing ... as Global Technical Owner for the relevant area.ResponsibilitiesResponsible for the design , configuration, customizing and further development of the relevant SAP… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description - The Program Coordination & Digital Design Specialist will report to the Animal Health Learning & Development (L&D), Program & ... lobal , Commercial, and Manufacturing Animal Health learning programs and design initiatives, ensuring an impactful learner experience. Program r esponsibilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process optimization to deliver measurable results through the engagement in design and develop methodologies, pursuing the implementation of projects and monitoring ... agent to promote a culture of continuous improvement and quality awareness. Design , deliver and implement training programs worldwide to enhance employee engagement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level. Responsible for clinical program planning and execution (from study design , operational planning, start-up, conduct, reporting, and close out) including ... plans are in place for all studies falling under their responsibility. Design , update and implement appropriate innovative and best-in-class procedures and SOP's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary Position leads complex studies in study design , statistical analysis and interpretation of results with some supervision. This ... report (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)
- …brand strategy and initiatives. including peer to peer digital programs. Manage the design and management of brand websites.Ensure projects are executed in a timely ... Analysis, etc. Present to various internal management committees and groups. Design and manage well-researched patient promotional and educational campaigns.Manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a physician's perspectiveMay provide clinical input into the eCRF (Case Report Form) design , participate in the UAT (User Acceptance Testing) and CCG (CRF Completion ... collaboration with the other authoring functionsAccountable for Protocol content/study design developmentContributes from a medical strategy standpoint to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary Responsible for managing the design , development, optimization and administration of global HCM Platforms and processes. ... knowledge and understanding of system features, capabilities, functionality and limitations. Design and architect end-to-end solutions, integrating the Global HRIS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with ... Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV… more
- Merck & Co. (Rahway, NJ)
- …Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our company's Device ... & Process Development (DPPD) Team, which focuses on the design , development, and commercialization of novel biologic/drug/vaccine-device combination products for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in internal and external cross-functional meetings or other relevant activities.Quality by Design (QbD) and Continuous Improvement: Provide support to the BPQLs and ... GQLs by reviewing and providing input during the development and implementation of Protocol (study level) and Global and Local policies and procedures (system level).Provide guidance, with oversight by RD Quality team members, during the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates ... as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with various communication-based tasks supporting Global R&D helping write, design , and create visual content (eg, videos, PowerPoints, infographics); assisting ... efforts to define, develop, manage, and execute communications strategies; assist in planning, writing, and managing key message documents and talking points for key spokespeople in Global R&D research and collaborate with staff on best practices, new ideas,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems including best practices of data security, role & security model design , hierarchical security, compliance and CAPA response & management; knowledge of ... industry standard clinical technologies including, EDC, Clinical Data Repository; knowledge of CDASH and CDISC data standards; knowledge and understanding of data acquisition and integration tools and technologies; knowledge of data snapshots, data cuts and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data and programming standards; emerging data capabilities and methods. Implements quality-by- design approaches to confirm the quality, integrity, and fit-for-use of ... the external data based on appropriate and/or established data-cut-off as a pre-requisite for database lock. Operational Efficiency / Continuous Improvement: Provides leadership for operational efficiencies and productivity gains through improved programming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Early-Stage assets for assigned assets and indications- Lead the enhancement, design and implementation of current and new forecast models to support the ... growing needs of the OBU- Maintain with latest insights and CI all relevant forecast models to inform quarterly LE's, AF's as well as mid long-range financial planning cycles and governance milestone decisions including DP's- Ensure alignment with Global and… more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionAs Director, Product Design at Formation Bio, your primary focus will be translating business ... opportunities, user needs, and tech innovations into impactful design solutions that accelerate drug development. You'll collaborate closely with cross-functional… more
- Merck & Co. (Rahway, NJ)
- …you will play a pivotal role provide support for SAP authorization strategy, design and execution in both production and non-production SAP systems.What will you do ... input on technical strategy and best practices to support SAP authorization design .Provide SAP GRC specific guidance for projects and process improvement initiatives… more
- Merck & Co. (Rahway, NJ)
- …This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and ... design control and risk management techniques to positively support...Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution… more
