- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team ... site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations... quality metrics and share with study team, Operations Program Lead, and Sr. Director for… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global ... at the forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with several… more
- 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 ... Clinical Study Start-Up activities for PV Safety Operations...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong… more
- Insmed Incorporated (San Diego, CA)
- …clinical operations , toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality , and biostatistics.Provide medical leadership for key ... development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials, through to full development.Serve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Merck & Co. (Rahway, NJ)
- …manufacturing -with a Quality First, Safety Aways Mindset. -The Director Manufacturing Operations (m/f/d) leads teams responsible for Technology Transfer, ... Clinical Supply and Technology Innovation implementation into the pipeline.The Director Manufacturing Operations (m/f/d) leads an Operating Unit responsible… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssoc. Director of Support Operations (m/f/d)The Biotech facility embeds the latest technologies into the early stage clinical pipeline, ... Phase Clinical Supply and Technology Innovation implementation into the pipeline.The Assoc. Director of Support Operations (m/f/d) will be a member of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OED; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes ... Collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations , Non- clinical , Clinical , and ... approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will… more
- Merck & Co. (Rahway, NJ)
- …complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP Operations , will oversee laboratory compliance across multiple ... Job Description Job Description: The GMP Operations branch of Biologics Analytical Research & Development...sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA… 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....ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department… more
- Merck & Co. (Lower Gwynedd, PA)
- …robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated ... Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Director to lead the Regulated Robotics & LIMS team...be to set strategic and scientific direction and drive operations within the Regulated Robotics & LIMS team. -… more
- Merck & Co. (Lower Gwynedd, PA)
- Job DescriptionAbout Us: The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab ... robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated… more
- Merck & Co. (North Wales, PA)
- …a health authority regulated environment - Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes ... Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible for managing the development… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process qualification, packaging and labeling. This position will interface with Operations , Regulatory, Quality Assurance, Finance, R&D, Project Management and ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...coach cross functional team staff in areas such as quality , compliance, safety, project planning, process development, technology development.Communicate… more
- Insmed Incorporated (New York, NY)
- …insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include trial ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence. Support business functions in determining PV relevance for ... of safety data between partners in relation to marketed and clinical products.Strategic Partner Management:Oversees Local/Global PV service providers responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …record keeping and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling ... record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
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