- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager , Team Manager (GCTM-TM) is responsible for line ... support across trials as needed and may assume Global Clinical Trial Manager (GCTM) responsibilities to address fluctuating demands throughout the trial… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleGenmab is seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug ... trial supplies for both early- and late-stage clinical trials.As a Clinical Drug Supply Manager , you will manage the packaging and labeling of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the ... maintenance of standard hierarchy structures and user access controls for all clinical studies. This position may have direct reports and/or dedicated external… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical ... Supply Operations team.As Senior Clinical Drug Supply Manager you will play a pivotal role in ensuring...pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as needed.QualificationsSuccessful candidates will be able to meet the ... position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as needed.QualificationsSuccessful candidates will be able to meet the ... position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as neededQualificationsSuccessful candidates will be able to meet the ... This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical ... Monitor. Represents Clinical Development on Study Team and collaborates as team...with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance Manager ... program for the site Quality Control laboratories in support of both clinical and commercial manufacturing. This role will be responsible for managing Laboratory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Job Summary: This position resides within the Functional Excellence and Clinical Biomarker Oncology department of the Global Precision Medicine function. The ... Manager , CDx Diagnostics Scientist's primary responsibilities are:Assists in defining...in defining the biomarker assessment and implementation plan for clinical trials.Executes biomarker testing and data capture at central… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Program Manager , Cleaning Validation as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Program Manager , ... CAR-T Environmental Monitoring Immediate Action team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.Key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible ... for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Proactively seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, Biomarker, ... CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… 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 ... quality, and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role...to PDPs from NNI PDP Forum Partner with Project Manager to track workstreams under the Project Teams Provide… 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 ... adds to content in comprehensive evidence-based medical information (eg, clinical overviews, formulary dossiers, online evidence repository) Performs quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% Occasional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes preferred Ensures timely execution and follow-up. Meets deadlines ... Intermediate proficiency in Windows, MS Word, PowerPoint and Excel required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... the strategic objectives of the organization by bridging the gaps between clinical science and commercialization of our portfolio. The position is dedicated to… more
