- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and ... people at different levels are also some of the requirements of this role. The Manager , Clinical Data Standards should be a subject matter expert in clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience as a Clinical Trial/Project Manager Experience with global clinical trial operations, in multiple phases of research Strong knowledge of ICH ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are...difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a… more
- Merck & Co. (North Wales, PA)
- …mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to ... DescriptionThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have… more
- Merck & Co. (Rahway, NJ)
- …and key strategic engagements. This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage ... team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents. Partners with Study Manager on study deliverables.Participates… 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
- 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
- Genmab (Plainsboro, NJ)
- …purpose.The Role & Department As a Senior Programming Associate or Programming Manager , you will be in the Statistical Programming team and Development Operations ... leading a small team to complete various programming efforts within a clinical trial.You will be responsible for ensuring integrity, consistency, and adherence to… 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)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads ... address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal… 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
- 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 ... MD, DO, PhD, or PharmD required A minimum of 5 years of combined clinical , research or Pharma experience required MD/DO with significant US clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Job Summary: This position… 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
- Genmab (Plainsboro, 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
- 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
- MD Anderson Cancer Center (Houston, TX)
- …for a maximum of two years of supervisory or management experience. Preferred: Clinical Research Regulatory QA **OTHER:** Required: Must pass pre-employment ... The primary purpose of the Manager , Clinical Protocol Administration position is...research team and Principal Investigator (PI) to coordinate clinical trial quality assurance, submission and regulatory … more
- Dana-Farber Cancer Institute (Brookline, MA)
- …(RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager , Clinical Research Manager and / or directly ... current regulations, regulatory guidance and or local policies. + Assists Clinical research Manager with regulatory based training and implementation… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …knowledge of current regulations, regulatory guidance and or local policies + Assists Clinical research Manager with regulatory based training and ... (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and /...the Clinical Trials Office to complete the regulatory requirements of the clinical research… more
