- 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 ... Plans and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... 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)
- …as 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug...with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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, Translational Research, Research,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .-...with data manager to ensure high quality data .- Drug Development Strategy: Provides input to multiple aspects… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a ... of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange Requests for PV Systems Collaborate cross… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... single or multiple clinical trials from strategy outline through to CSR by...to IEC/IRB commentsMonitor major protocol deviations (PDs) and trendsApprove data cleaning plansCollaborate with CPL as needed for CST/CDTEstablish… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... the relationships with the clinical vendors as well as coordinate and manage outsourcing...of internal and external stakeholders (eg Scientists, Trial Managers, Data Managers, Clinicians, vendors) to support the overall development… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development ... and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information)...Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… 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 ... DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure...MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding experience in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data ... (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level… more
- Bristol Myers Squibb (Princeton, NJ)
- …sustainability and success of the BMS R&D pipeline. This role reports to the Director , Clinical Data Management or Associate Director , Clinical ... treatment we pioneer. Join us and make a difference. The Senior Manager, Clinical Data Management ( Data Management Lead) is a role considered essential to… more
- Bristol Myers Squibb (Princeton, NJ)
- …design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data . Associate Director drives the ... development and implementation of innovative strategies and technologies for clinical trial programming. Associate Director ...medical terminology used in the analysis and submission of clinical data + Broad expertise in statistical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external ... master file is complete and accurate for assigned stud(ies). + If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for… 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 ... based in Branchburg, NJ or Irvine, CA. Responsibilities: The Associate Director will be responsible and accountable... content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions, and… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Advanced Degree in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+ years experience with demonstrated ... and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data … more
