- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role Overview ... The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for...the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview The ... QC Data Reviewer is an exempt level position responsible for reviewing...related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and ... Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical...budget allocation, and assessment of needs including training, data review tools, etc.Standing PRG reviewer for mid-to-late-stage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of medical review , providing expertise and guidance as lead Medical Reviewer on PMRT. Ensure appropriate early medical guidance and scientific direction is ... Associate Director (AD) is responsible for overseeing all activities related to Medical Review for their assigned Therapeutic Area (TA). The AD is accountable for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...into study protocol profiles, final protocols and amendments.Lead document review & coordination for the protocol and amendments. Additional… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical ... operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development, maintenance, and ... - Leadership, Direction, and Strategy:Leads implementation of Therapeutic level clinical data collection requirements including cross-functional standards initiatives by… more
- Merck & Co. (North Wales, PA)
- …relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data Integrations, ... and Trial Data Review solutions are the mechanism used to ensure the...trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety… more
- Eisai, Inc (NJ)
- …providers and managing service provider business relationships in alignment with global strategies. Review and approve Clinical Quality Assurance audit plans and ... to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities...lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs)… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director, Clinical Development will play an important role in working with the team ... to execute the global clinical development plans of brensocatib for the HSindication. Tasks...authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trial start-up strategies Provides system and device expertise to train and support clinical trial sites Ensures ongoing collection and review of relevant ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …providing the safety leadership and serving as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant ... signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness.- Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; ... Represents clinical function at meetings with health authorities; Oversees management...dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and quality check of data,… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic ... management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study Reports).Leads and drives the data review process in ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they… more
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