- Genmab (Plainsboro, NJ)
- …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) ... to work according to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager, of the following tasks:Global Clinical Drug … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... accountable for operational planning and execution at the study level with responsibility for clinical study plan and execution...with internal Functions within the study team to ensure drug destruction process and other study close out activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manager as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt- level position is responsible for performing a wide range of activities to support ... the release of drug products for human use. This position is responsible...all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug … more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role modelEnsures consistency of statistical methods and… more
- Merck & Co. (South San Francisco, CA)
- …bench scientist to drive assay development and optimization to support drug development, target identification and validation activities in close partnership with ... optimization in retinal and/or vascular diseases. This position requires high level of motivation and dedication to lab experimentation with excellent comprehension… more
- Merck & Co. (Rahway, NJ)
- …& Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... set direction for the device development strategy for multiple drug -device combination product development programs ranging from concept generation/selection,… more
- Merck & Co. (South San Francisco, CA)
- …Disease Therapeutic Area is seeking a driven and creative Scientist to join our drug discovery team. This is an exciting opportunity to directly contribute to ... drug target identification and validation activities in close collaboration...minimum of 3 years of industry experience with high level of motivation and dedication to lab experimentation with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development ... Global Team leader as the Project Management lead on drug development projects. This position can be assigned to...position is also accountable for supporting divisional and departmental level objectives and may also lead a non-project initiative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input to multiple aspects of the development… more
- Merck & Co. (Rahway, NJ)
- …Development Team and/or Early Development Team stakeholders.- Set protocol- level , hypothesis-driven translational science and biomarker strategy.-Collaborate with ... and achievement.Ability to demonstrate a broad understanding of the end-to-end drug and diagnostic development process, and specific expertise in oncology,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the development ... or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex… more
- Merck & Co. (Rahway, NJ)
- …and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, robust and productive processes, ... assessments, deviation investigations, and Good Documentation Practices (GDPs).-A high level of innovation, creativity, and self-initiative along with the ability… more
- Insmed Incorporated (San Diego, CA)
- …and scientific support to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program ... for meetings as it related to the protocol(s) and program Provide protocol level scientific review of information to support the development and updates for… more
- Merck & Co. (Rahway, NJ)
- …scientific community. Scientific exchange does not include promotional claims about any drug , vaccine or biologic product. RMSDs provide to Scientific Leaders (SLs) ... investigator questions.May initiate discussion with potential investigators to determine the level of interest and qualifications for a specific compound or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and with CROs to execute study start up processes. This level will handle problems requiring escalation from others and make decisions where appropriate ... with Data Management, establish the EDC strategy at the project and/or study level . Proactively identifies and manages risks at the project and/or study level… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to achieve the Target Product Profile (TPP)Development of clinical sections of trial- level regulatory documents (eg, response to HAs, briefing book, etc.) in ... overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents, in… more
- Aequor (South San Francisco, CA)
- …support the overall safety assessment for our Client therapeutics spanning drug discovery through clinical development and marketing. The group provides ... platforms / approaches to support toxicity testing for our drug discovery programs. This is an ideal position for...study integrity and quality. Conducting experiments with a high level of independence and initiative. Performing tasks with minimal… more
- BioAgilytix (San Diego, CA)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... related field, with a strong focus on supporting a CRO, CMO, or drug development organization. Working knowledge of selling GMP CMC analytical development and… more
- Novo Nordisk Inc. (Boulder, CO)
- …so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP ... experience in the pharmaceutical, biotechnology or related industry focused on drug development and manufacturing Strong background in oligonucleotide-based drug … more
- Merck & Co. (North Wales, PA)
- …, partnering with team lead s to develop strategies and execute our Company's drug and vaccine development efforts to progress the R&D pipeline . The Associate ... Experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle...of project initiative status and issues at the right level of detail Demonstrated ability to serve as a… more
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