- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label Development process which includes ... preferredExperience Qualifications7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or Pharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review, Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of...process standards and tools to achieve excellence in trial operations and management .Monitor and ensure compliance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations . This position ... (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years relevant experience is required with a BSc requiredExperience in clinical operations methods and processes in industry setting requiredExperience ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with external CROs, collaborate and represent QCP on internal teams including Clinical Development Operations , Global Project Management , Bioanalysis, and ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Merck & Co. (Rahway, NJ)
- …writing, and presentation skillsEducation/ExperienceBachelor'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...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current clinical practice and ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Exchange, and Dashboards. And in the R&D space including but not limited to clinical trial management system, drug labeling, and learning management ... supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people...contact of R&D areas including but not limited to clinical trial management system, drug labeling, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labs or analysis labs in collaboration with relevant stakeholders including Data Management , Clinical Operations and QCP/CDx/ Clinical BiomarkersSupport ... centered around rare diseases and immune disorders. Job Summary The Biosample Operations Manager, Biosample Management is responsible for supporting the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Budget in support of Phase I-III clinical studies. Partner with Project Management , Clinical Operations and other functional groups to ensure budgets ... Coordination with all functional areas impacted including Legal, Procurement, Project Management and Commercial or Corporate Finance, Operations . Liaison to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... is responsible for working with the business lead to ensure effective team operations through meeting management , development plan/timeline management , scope… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management , and other ... oral and written reports to effectively communicate results of clinical trials to the project team, Company Management...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal stakeholders including members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations , Biostats and Data Management and ... IVD Development Process, with direct experience with Companion Diagnostics implementation in clinical trials and companion diagnostics operations is a plusSolid… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a global matrix of biomarker and translational scientists and clinical operations . The candidate must have effective project management skills and ... and timely fashion. Collaborate with Translational Scientists, Companion Diagnostic Scientists and Clinical Scientists and Operations Leads in the review of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution plans across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and ... tailored for AEs from end-to-end: understanding predisposing non- clinical and clinical factors, diagnosis, effective management during clinical trials… more
- Merck & Co. (Rahway, NJ)
- …fast-paced job that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Lead position will report to ... at the Associate Director level will serve as a technical mentor and operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative ... Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative ... Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics… more
- Merck & Co. (Rahway, NJ)
- …The Executive Director in Medical Writing will be responsible for overseeing clinical trial data registration, results postings, redaction operations , external ... and compliance with global disclosure requirements. Primary Responsibilities:Responsible for clinical trial data registration, results postings, redaction operations… more
