- Daiichi Sankyo, Inc. (Bernards, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global … 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. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase ... I-III clinical studies.Partner with Project Management, Clinical Operations and other functional groups to ensure budgets...Budget Planning - Manages and is accountable for the development and control of functional budget in support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& ManagementOversight of Data Request processing by Service ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and ... 8.0.x and 7.0.x Patches.Experience with SQL programming/querying, custom report design/ development from Argus Safety backend database.Strong knowledge of Oracle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development , Clinical Scientists, Clinical ... integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management ... including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- J&J Family of Companies (Raritan, NJ)
- Johnson and Johnson Innovative Medicine is recruiting for an Associate Director , Global Oncology Competitive Intelligence & Market Research - Lymphoma, Leukemia ... can reach their potential. At Johnson & Johnson, we all belong. The Associate Director , Global Oncology Competitive Intelligence & Market Research - Lymphoma,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Vendor Management, is responsible for assessing, onboarding, and overseeing the health and performance of vendors involved in clinical ... teams to ensure cohesive vendor management practices. + Engage with Development Services and Operational Excellence's (DSOE) Change Management function to facilitate… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Statistical Programming manages the statistical programming group within the therapeutic area(s). The incumbent oversees all activities, ... service providers, related to statistical and non-statistical analysis on clinical program(s). The incumbent identifies and communicate therapeutic specific… more
- AbbVie (Branchburg, NJ)
- …supporting Product Safety Leads (PSTs) to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making and risk mitigation for ... diligence activities. Responsibilities: *Understand and apply pharmacology, chemistry and non- clinical toxicology to effectively conduct safety assessments *Contribute to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Responsibilities - Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase ... I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets...Budget Planning - Manages and is accountable for the development and control of functional budget in support of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.** **Responsibilities:** - Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
