- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant policies, procedures, and regulations. This position will participate as a member/medical reviewer of the Product Material Review Team (PMRT) and as a ... and is compliant with all applicable policies and regulations. Participate in medical review , providing expertise and guidance as Medical Reviewer on PMRT.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study ... creation of SAE Flow Plans and may perform final review . This position provides input on electronic data capture...on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external vendors/partners to execute responsibilities.- Responsible for review , approvals, categorizing, prioritizing, of change requests.- Analyze Service ... Requirements in business to define/revise service levels. Facilitate regular business reviews with all partners and provide performance summary analysis, and gap analysis to ensure that the right tools and processes are available to deliver the best customer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... and document issuance and reconciliation.Key Responsibilities Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and approval in accordance with ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...Develops detailed bid analysis for the RD functional group's review . Development and management of other ad hoc special… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality ... including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development, Clinical Scientists, Clinical Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo...the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position ... requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical ... of the Biostatistics and Data Management teams on various clinical projects and may function as the Lead ...CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems.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...for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase to late-stage clinical ... management and to external party for the collaboration program. Participate in the review and analysis of quarterly financial results against plan and monitor key… 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 ... CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development project meetings. Conduct completeness, scientific accuracy, and ease of review of the submissions. Provides guidance to peers and cross-functional team ... DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate group within the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities ... QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP clean room environment.Ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities ... sampling, related to the manufacturing of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.Work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... This individual will support organization build and ramp-up of clinical production and facility approval of a state of...parts and spare parts are identified and availablePerform work review , approval and close out of work orders, including… more
