- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... Clinical Study Start-Up activities for PV Safety Operations...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong… 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)
- …in support of Phase I-III clinical studies.Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always ... for the development and control of functional budget in support of global operations of RD unit.Partner with global function leaders to ensure budgets are always… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… 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, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Local DSI CSPV SystemsMonitoring disruptions in customer service and internal operations , while ensuring the highest level of qualityCollaborate with internal ... a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving global ... Clinical Study Start-Up activities for PV Safety Operations...where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires… 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
- AbbVie (Florham Park, NJ)
- …appropriate scientific and medical activities with internal stakeholders (ie commercial, clinical operations , discovery, statistics, regulatory, etc.) as they ... level will be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational… 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 ... reviews and updates of business continuity plans. + Ensure minimal disruption in clinical trial operations through effective continuity planning. + Contribute to… more
- AbbVie (Branchburg, NJ)
- …Lead, Search and Evaluation Team, Project Management, Regulatory Affairs, Discovery, Clinical Operations Additional Information Applicable only to applicants ... supporting Product Safety Leads (PSTs) to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making and risk mitigation for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in support of Phase I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always ... for the development and control of functional budget in support of global operations of RD unit. Partner with global function leaders to ensure budgets are… 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, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- IQVIA (Parsippany, NJ)
- …operating porcedures or cross-functional standard operating porcedures owned by other operations ; * May support global regulatory or technical initiatives or act ... and/or other regulatory bodies IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation. +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Local DSI CSPV Systems + Monitoring disruptions in customer service and internal operations , while ensuring the highest level of quality + Collaborate with internal ... + Has a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical Trials + Ability to extract configurable data fields from a study… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …City, CA. This is NOT a remote position **RESPONSIBILITIES:** + In partnership with Clinical Program Manager or Associate Director , provides guidance and ... fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** ** CLINICAL OPERATIONS :** Clinical Operations is responsible… more
- Interstate Blood Bank (Lehigh Valley, PA)
- …responsible for driving sales and business development activities related to clinical biospecimens and biobank services. This role involves building and maintaining ... sales activity including customer visits, training, exhibits, etc. + Partners with Operations to ensure prioritization of product production to meet key account… more
