- 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)
- …a lead Global Clinical Supply Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate ... Job DescriptionThe Global Clinical Supply organization is accountable for managing the...software . - Familiarity with Good Manufacturing Practices (requirements, quality procedures, and Standard Operating Procedure execution. - -… 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 ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full of our Research… more
- Merck & Co. (Rahway, NJ)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Job DescriptionOur Clinical Development teams manage studies to provide the...Director) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and… more
- Genmab (Plainsboro, NJ)
- …Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In addition, ... purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global ...Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Genmab (Plainsboro, NJ)
- …areas for improvement and drive process enhancements.Align GCDS efforts with Quality Assurance, Clinical Strategy, and other stakeholders.Address drug supply ... purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global ...driven and proactive player with responsibility to deliver high quality trial supplies on time from an planning perspective.… more
- Merck & Co. (Rahway, NJ)
- …role involves close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs ... lead our data management team in supporting the pharm and vaccine veterinary clinical trials. The ideal candidate will be responsible for overseeing the development… more
- Merck & Co. (North Wales, PA)
- …protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and ... SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... therapy.A minimum of 2 years of experience with quality support in clinical manufacture is preferred. A minimum of 1 year of leadership experience is also… 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 ... analytical data visualization and conduct predictive analysis to increase the efficiency of clinical data review and clinical operations with the ultimate goal… 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 ... functional cohesiveness across SOPs and related documents related to clinical trial execution.Responsibilities:Development SOP Landscape Develop and maintain overview… 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 ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our Company's Research Laboratories portfolio… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... 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
- Genmab (Plainsboro, NJ)
- … quality standardsManage a team of 25+ scientists within Clinical Pharmacology and Quantitative Sciences (CPQS) comprising of Quantitative Translational ... purpose.Genmab is looking for a dynamic, science-driven people leader to head our Clinical Pharmacology & Quantitative Sciences team. Do you get excited by our well… more
- Merck & Co. (Rahway, NJ)
- …optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business processes.Core Responsibilities may include and are not limited ... Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for...responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety global business processes. This includes defining and… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) ... locations to work according to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager, of the following tasks:Global Clinical … 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 ... provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical Study Oversight… more
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