- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- 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)
- …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)
- …+ Ensures trial master file is complete and accurate for assigned stud(ies). + If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- AbbVie (Branchburg, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Clinical Development will have global or ... position may be based in Branchburg, NJ or Irvine, CA. Responsibilities: The Associate Director will be responsible and accountable for the development,… 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
- 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
- IQVIA (Warren, NJ)
- …+ Builds client relationships across the client organization, including commercial operations , data governance, market research, forecasting, sales operations , ... + Coordinates business development and service activity with the Account Director , Sales, Consulting and Service Specialists to validate opportunities to achieve… 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)
- …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. (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
- 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
- Elevance Health (Morristown, NJ)
- …quality, cost, and outcomes. May provide clinical consultation and serve as clinical /strategic advisor to enhance clinical operations . May identify cost ... **This position is hybrid and will require the associate to report to the office at least...Director Associates. May be responsible for an entire clinical program. **How will you make an impact:** +… more
- Terumo Medical Corporation (Somerset, NJ)
- Director of Sales, North America - PSD Date: Jan 6, 2025 Req ID: 3783 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: PSD Terumo ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… more
- RWJBarnabas Health (Somerville, NJ)
- …of best practices and processes + Partners with Regional Manager, Regional Director of Operations , Practice Providers, and Quality Department to standardize ... the system's clinically integrated network + Works closely with Regional Manager, Regional Director of Operations and Providers to ensure practice site is… more
