- Primastep LLC (Arlington, VA)
- …(IRBs, investigators, institutions) Developing or applying policies aligned with human research regulatory frameworks Working knowledge of relevant federal, DoD, ... Description Job Description We are seeking a qualified HRPP Regulatory Compliance Specialist to support the Office of Naval... Compliance Specialist to support the Office of Naval Research (ONR) in Arlington, VA. This role ensures the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …curricula for different roles within clinical operations, medical affairs, and regulatory affairs Maintain training assignments on clinical research ... regulatory requirements Coordinate mandatory compliance training for clinical research staff, including GCP certification and recertification programs Support… more
- Jazz Pharmaceuticals (Redwood City, CA)
- …cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative ... oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative ... oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(Master's degree preferred) 3+ years of experience in pharmaceutical training, clinical research , or regulatory affairs ATD certification a plus Proficient ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings with ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Oversees Local/Global… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical ... is responsible for protocol development and medical/ scientific oversight of clinical research studies involving new or marketed drugs in the Vaccines Clinical … more
- Merck & Co. (North Wales, PA)
- …Curiosity, Interdisciplinary Problem Solving, Neuropathic Pain, Neuroscience, Neuroscience Research , Pain Management, Pharmaceutical Development, Regulatory ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Merck & Co. (Boston, MA)
- …Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be… more
- Merck & Co. (MA)
- …has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Merck & Co. (Rahway, NJ)
- …and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires ... and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Principal Scientist/Director, Value & Implementation (V&I) Outcomes Research , position resides in the V&I organization, which includes Global ... Medical and Scientific Affairs as well as Outcomes Research .Under the guidance of a senior leader, this position supports value evidence outcomes research plans… more
- Merck & Co. (North Wales, PA)
- …of an Executive Director, within the Value and Implementation, Outcomes Research the incumbent has the following responsibilities:1) development of the integrated ... and/or vaccines on a worldwide basis and3) development and implementation of Outcomes Research (OR) and Real World evidence programs to meet the value evidence needs… more
- Formation Bio (New York, NY)
- …trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of ... to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional… more
- Merck & Co. (South San Francisco, CA)
- …and external clinical study support staff and scientists (including discovery research , biostatistics, drug metabolism, modeling and simulation, regulatory ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout… more
- Merck & Co. (Rahway, NJ)
- …position involves interaction with Medical, Data Coordination, Statistical Programming, Research Laboratories scientists and Regulatory staffs in designing ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Associate Director, Clinical Research Scientist will support and work predominately with the Medical Monitor for ... This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well as overall program support… more
- Insmed Incorporated (NJ)
- …and teamsProven ability to work within a multi-functional team (legal, regulatory , clinical/medical, quality, research , etc.)Able to multi-task and prioritize ... Insmed's Medical Information Standard Operating Procedures and in-line with Regulatory Authority regulationsConducts advanced literature searches for education and… more
- Insmed Incorporated (NJ)
- …with project goals including Manufacturing, Analytical Development, Quality Assurance, and Regulatory , with input from Commercial, Research , and Clinical.Prepare ... functional areas throughout all stages of product development, including Research , Preclinical, Clinical, Regulatory , Operations, Quality Assurance.Innovative… more
- CHRISTUS Health (Longview, TX)
- …safety requirements resulting in positive patient outcomes. Supports nursing research and quality improvement activities. Provides evidence-based nursing care. ... that encourage attention to compliance issues, all clinical activities. Healthcare Regulatory Environment Implements programs as needed to comply with diverse… more