- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Genmab (Plainsboro, NJ)
- …to 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 ... office locations to work according to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global … 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …mentorship to other clinical scientist.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability ... 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 (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of ... clinical projectsExperience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsSome experience with operational management and budget… more
- Merck & Co. (North Wales, PA)
- …accuracy and integrity.-Collaborate with other departments: Collaborate with departments such as clinical , regulatory , and safety to ensure that PV processes are ... communication, and leadership skills, as well as a thorough understanding of regulatory requirements and quality standards. -Knowledge of Research and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …models. Complies with the protocol, Policies, SOPs, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical… 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 ... Budgeting and Outsourcing. This position requires strong collaboration with stakeholders across Clinical Medical and Regulatory (CMR), including the NACO senior… more
- Merck & Co. (PA)
- …background and leadership skills to join our team as the Regional Cardiovascular Lead Manager for the East District. In this role, you will lead and manage the ... overnight travel, and for meetings at HQ.The Regional Cardiovascular Lead Manager will report to the Director of Regional Cardiovascular Team.-Primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The ... Manager , Data Programmer is a member of the Biostatistics...drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The ... Manager of CRA Monitoring Oversight and Excellence is responsible...ensuring oversight of Central Monitoring activities according to the Clinical Monitoring Plan inclusive of trend identification, impact assessments… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryAs a … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... or More Years with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Genmab (NJ)
- …purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Staying Current on Current Market Trends : Stay up to date on the latest clinical research and best practices related to our products and therapeutic areas, ... Are you ready to experiment with us? The Position The Educator Strategy Manager will play a vital role in developing healthcare professional (HCP) education strategy… more
- Merck & Co. (Rahway, NJ)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management...Project and Alliance Management (GPAM) which sits in the Research & Division organization of our company. - Position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads ... Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Responsibilities:- Protocol ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Johns Hopkins University (Baltimore, MD)
- Under limited supervision of the Sr. Clinical Research Program Manager , we are seeking a **_Clinical Research Regulatory Specialist_** who will be ... compliance and continuing education trainings for the specific Urology Clinical Research Program. Regulatory start-up...is the coordinating center, work closely with the project manager to collect and review regulatory documents… more
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