- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Develops and updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label Development process which ... preferredExperience Qualifications7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(PrM) will be responsible for managing a broad spectrum of PrM activities as project manager , which includes but not limited to plan/schedule, manage budget and ... contract, keep project information up to date, liaison with internal and...deliverables at multiple decision points in the Global Drug Development Process. Authors meeting summary and drives action items… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Manager , ERP Applications is accountable for maintaining and modifying assigned ERP ... to the design and integration elements of each enhancement or project .Responsibilities:Responsible for developing high quality solutions based on Functional Design… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsibility: In conjunction with Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks at the ... project and/or study level as it relates to data...reporting to ensure quality and compliance in safety reporting.Procedure Development : Supports the process redesign activities to ensure compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External Vendors for the data services they provide to support drug development processes and global submissions. This position provides expertise within Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …their needs and factoring regional needs, laws, and requirements.- Collaborate with the Project Manager (PM), HCP Engagement IT Operations team and business ... and IT solutions. This position is responsible for overseeing the development , implementation, and maintenance of software systems that support business operations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Effective management, impact analysis, and resolution of escalated risks/issues by project manager (s)Program budget management including preparing and requesting ... with alliance partners to meet obligations related to the development , co-promotion, out-license, etc. of pharmaceutical products. Extensive knowledge...or More Years Progressive career path as a Program Manager and Project Manager of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the strategic oversight, planning, and execution of all non-regulated systems development and implementation within the organization. This role ensures that all ... in the creation of business cases and the preparation of Kessai and/or Project Entrustment documentation for budget approvals. The Lead will also manage vendor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...cGMP requirements. This individual will also oversee the hiring, development , and performance management of staff, and assign personnel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serving as a mentor in order to foster their professional growth and development as well as their achievement of Company and/or departmental expectations and goals ... Division of the Company. [Specific assignments to be determined by direct manager of the role.]- Creates, implements, and presents training programs and materials… more
- Merck & Co. (Rahway, NJ)
- …Requirement: Bachelor's Degree +9 years of pharmaceutical, clinical drug development , project management, and/or-medical field experienceOR Master's Degree ... +6 year of pharmaceutical, clinical drug development , project management, and/or-medical field experienceOR PhD/PharmD Degree +2 year of pharmaceutical, clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical support for low to medium complexity studies including contributing to development of optimal study design, follow and execute statistical analysis plan ... results with supervision. This position contributes to specific aspects of drug development plans with supervision and contributes to documents submitted to Health… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description As a Design Control and Risk Management Data Manager , you are a key member of the Device Development Team. Your will main ... to develop and manage the data relationships through the development and life cycle of a product. Key responsibilities... and post market.Utilize library data to drive cross project consistency.Become the IT system SME and trainer.Drive continuous… more
- Merck & Co. (Rahway, NJ)
- …be more productive and enable innovation. The AH SAP Technology team (Basis, ABAP Development , Authorizations, and Integrations) is part of the EPM team and plays a ... self to discussions that are relevant from a technical point of view.Lead project teams by working in partnership with Project Managers. Review infrastructure… more
- Merck & Co. (Rahway, NJ)
- …resource planning and IT master data management.The Demand and Capacity Management Product Manager plays a critical role in the BIT program at our Company. This ... work and portfolio management tools like Jira, Apptio Targetprocess, and Microsoft Project .A minimum of 2 years' experience in a leadership roleAbility to recruit… more
- Merck & Co. (Rahway, NJ)
- …A successful candidate should possess prior application administration experience, strong project management skills and a curiosity for applying emerging technology. ... This is a people manager role and is responsible for managing two legal...deployment of technology solutionsLeverage cross-functional relationships to influence the development and adoption of new processes/technologies to make a… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... & Architecture, s/he is the Global IT department's trusted leader and manager who assesses and provides objective risk assessments and guidance regarding Eisai's… more
