- Merck & Co. (Rahway, NJ)
- …strong understanding of local regulatory environment. Strong scientific and clinical research knowledge is required. Strong understanding of clinical ... ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and… more
- Merck & Co. (Rahway, NJ)
- …present technical information with support .Good understanding and working knowledge of clinical research , phases of clinical -trials, current GCP/ICH & ... research experience. Related CR experience may include Clinical Trial-Assistant, Study Coordinator, Regulatory CTC or… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A minimum of 5 years' experience required (Pharmaceutical industry, laboratory, or clinical research experience) An intermediate to advanced proficiency in ... About the Department The Clinical , Medical and Regulatory (CMR) department...ready to make a difference? The Position Provide proactive support and technical assistance to more experienced regulatory… 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
- Merck & Co. (Rahway, NJ)
- …by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.Review and provide ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… 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
- 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 ... and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products Create and maintain product/project… more
- Merck & Co. (North Wales, PA)
- …team-members including clinical directors and study managers to lead/ support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the ... the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in support of the ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …methods and processes in industry setting. required Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical ... device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has ... vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, ... team through creation of briefing materials and meeting preparation Lead and/or support global filing activities for submissions Present regulatory strategies… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... Nordisk (eg, clinical trial site staff, IRBs, clinical research vendors). Manages relationships with multiple...regulatory requirements and ICH and GCP guidelines Provides support to prepare for and follow-up on audits and… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development: Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function ... of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of… more
- Eisai, Inc (Nutley, NJ)
- …accordance with agreed to development plans and corporate objectives. Advanced understanding of clinical research and the clinical drug development process ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...we want to hear from you. JOB SUMMARYThe Director, Clinical Project Management will manage assigned project (s), including… more
- Merck & Co. (Rahway, NJ)
- …strategies with corporate goals and providing critical therapeutic area insights.Recognized clinical research expert in areas such as atherosclerosis, ... Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be… more
