- 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)
- …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)
- …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)
- …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
- IQVIA (Parsippany, NJ)
- …is aligned with IQVIA's Centralize Outsourcing Operations Hub (COOH) team. The Clinical Training Manager or Associate Director will be responsible for ... the development and implementation of learning programs for clinical -based roles with patients and healthcare providers in both the field-based and virtual settings.… 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
- Bristol Myers Squibb (Madison, NJ)
- …(WWMA) Cell Therapy (CT) Organization. **Details** This role reports directly into the Senior Director of Strategy and Operations and will be a strategic and ... across a matrix. * Experience with drug development, commercialization, and healthcare, clinical trial management a plus. **\#LI-Hybrid** If you come across a role… 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
- IQVIA (Parsippany, NJ)
- ** Associate Director , IQVIA Participant Payments (ADIPP)** The Associate Director , IQVIA Participant Payments (ADIPP) is responsible for directing a ... completion. + Direct the hiring and selection process of new Patient Solution Operations positions, by participating in the interviewing process. + Ensure that staff… 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
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The Associate Director , Drug Product External Manufacturing QA provides Quality oversight to ... Deviations, CAPAs, Change Controls, Batch Record Review, Lot disposition to support the clinical and commercial release of Drug Product. This role will also develop… more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** Associate Director , Portfolio Manager, Business Services and Capabilities, ... and communicate a portfolio of projects that enable late stage clinical and commercial operations for the CT Development and Operations (CTDO) business… 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
