- Insmed Incorporated (San Diego, CA)
- … development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials, through to full development.Serve ... of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality , and biostatistics.Provide medical leadership for key… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies . Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address ... and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders. Works directly in the SAP system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference ... and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs… more
- Merck & Co. (North Wales, PA)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Genmab (NJ)
- …activities related to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will ... the portfolio. The employee will also provide input to Genmab clinical drug development programs to ensure data management excellence.Responsibilities:Contributes to… more
- Aequor (South San Francisco, CA)
- …the Early Clinical Development (ECD) department is to optimize the support of clinical systems to provide high- quality clinical trial data insights and ... and conduct predictive analysis to increase the efficiency of clinical data review and clinical ...data-driven decision-making throughout the study lifecycle. The Risk Based Quality Management (RBQM) Data Analyst sits in the Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …10 year' experience in pharmaceutical or biotechnology development functions or clinical quality assurance required Experience Qualifications Experience:10 or ... coordinate with the appropriate stakeholders to ensure timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance… more
- Merck & Co. (Rahway, NJ)
- …lobal C linical T rial O perations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics . - Responsible and ... prepares , analy ze s , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Responsible and accountable for utilizing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Writing is a key role responsible for producing scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines. ... position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical… more
- Genmab (NJ)
- … clinical development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (ie, ... implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …function, health-related quality of life, or other patient-centric concept of clinical benefit Ensures the scientific quality and integrity of patient ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Insmed Incorporated (San Diego, CA)
- …internal teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plansContribute to ... development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program support...through final reporting of results Provide scientific input and review of clinical study data, support in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is… more
- Merck & Co. (Rahway, NJ)
- …of potential medical breakthroughs.Support statistical programming activities for Early Oncology clinical development projects. Review the quality and ... of clinical studies using deep scientific knowledge, statistical analysis and high- quality data to support decision making in clinical trials.Responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....implementation of strategies to maintain efficient and compliant Promotional Review Board (PRB) process Serve as a primary regulatory… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality systems team, ad hoc, for activities such as annual product review , site risk register, or internal quality agreements.Develops and delivers training ... promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support… more
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