- Merck & Co. (North Wales, PA)
- …(Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... Oncology (and/or Hematology)Prior experience in breast cancer idealPrior specific experience in clinical research and prior publication is desirable but not… more
- 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 ... and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research...role and responsibilities Drives recruitment and retention strategies to support clinical trial sites to meet country… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and… more
- Merck & Co. (North Wales, PA)
- …assess the operational and regulatory capabilities of DHTs and SaMDs, identify regulatory risks and requirements. In the clinical arena, RDH works with key ... groups within Global Regulatory Affairs, GCTO and others to implement the regulatory strategy for the DHT/SaMD in global clinical trials. Finally, in the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lessons learned, and enterprise-wide best practices.Reinforce DS commitment to inclusive clinical research by conducting presentations and trainings, where ... include oversight, training and mentoring of employee and/or contractor-based staff/analysts to support the overall delivery of a clinical trial diversity and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials- Stay abreast of industry trends and changes in regulations related to clinical research diversity and inclusion - Health Authority Interactions- Point of ... team of cross functional partners, including but not limited to: Global Clinical Operations, Global Regulatory Affairs, Biostatistics and Data Management,… more
- Merck & Co. (North Wales, PA)
- …events. The data collected from Clinical Trials are used to support drug applications and regulatory submissions to health authorities globally.Trial Data ... data is collected from trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety profiling and adverse… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Job DescriptionOur Research Scientists are our Inventors. We identify and...program deadlines.Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external scientific publications.Experience… 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 ... Evidence (CDSE) - Fellow is responsible for supporting planning and execution of observational research / Real World Evidence studies to support the Evidence and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in end-to-end clinical trial execution in one or more key functions (eg clinical research & development, clinical science, clinical quality ... and assesses their impact.Understand data/metrics/key performance and quality indicators to support vendor/CRO oversight of clinical trials.Maintain awareness of… more
- Merck & Co. (Rahway, NJ)
- …input into research and business development priorities and prioritization of clinical assetsMay serves as the senior liaison for relevant stakeholders in the ... external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … between studies in one or several programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other ... ensuring the highest scientific/medical standards in accordance with ethical and regulatory requirements across regions.- Interact with clinical investigators,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation ... governance, framework and culture of operational excellence. Metrics and Collaboration Opportunities: Support the clinical teams to generate metrics and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe primary objective of the Small Molecule Analytical Research and Development (SMAR&D) team is to carry out R&D activities partnering across the ... roles include the-development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw… more
- Tris Pharma (Monmouth Junction, NJ)
- …development plan for multiple, concurrent programs spanning all phases (I-IV)) of clinical research . The incumbent is responsible for establishing and overseeing ... as Medical Monitor for one or more studies, as neededCollaborates with assigned Clinical Research Organization (CRO) and/or Medical Writer to contribute to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate ... the company as needed.ResponsibilitiesManages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in end-to-end clinical trial execution in one or more key functions (eg clinical research & development, clinical science, clinical quality ... manage GCO Risk Management Plans (RMPs) (design, management, and maintenance) for global clinical trials.Provide day-to-day support to study teams and their line… more
- Insmed Incorporated (Bridgewater, NJ)
- …to support clinical dose and dosing regimen selection, facilitate clinical study design and support regulatory submissionsAuthor regulatory ... related inquiriesPreparation of abstracts and manuscripts for publicationClosely partner with Research , Clinical teams, Bioanalytics, Regulatory , Project… more
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. ... about twenty (20) percent of the time to manage future or ongoing clinical research projects. Qualifications Education MD, DO, MD/Ph.D, or DO/PhD.. Required… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... documents to the CRO and vendors as appropriate.- Provide clinical administrative support to the study teams....More Years with BS required- Experience considered relevant includes clinical or basic research in a Pharmaceutical… more
