- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic ... creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections… more
- Merck & Co. (Rahway, NJ)
- …commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ... (Principal Scientist)has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines.… 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 ... Summary: This 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
- Merck & Co. (Rahway, NJ)
- …for a Senior Scientist position available at the Rahway, NJ research facility. Join Small Molecule Analytical Research and Development and experience ... while developing and expanding your career.In your role as Senior Scientist, you will be part of a team...tools, and data analysis. You would also contribute towards regulatory submissions to enable clinical trials.Your main… more
- Merck & Co. (Rahway, NJ)
- …department of our Research & Development Division is seeking applicants for a Senior Scientist position available at our research facility. The Senior ... Job DescriptionSenior Scientist, Biologics Analytical Research & DevelopmentOur Research Scientists are...of methods for release, characterization, and stability testing of clinical trial material and in support of product and… more
- Merck & Co. (South San Francisco, CA)
- …Responsibilities:Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support ... reports. Interact with colleagues from multiple areas, including discovery, regulatory affairs, project teams, and development functions.Partner with scientists and… more
- Merck & Co. (Rahway, NJ)
- …appropriate resourcing for the company's internal clinical trial portfolio.Partner with Clinical Research Organization (CRO) Senior , Regional and local ... Job DescriptionOur Clinical Research and Pharmacovigilance team push...are important interactions with, inter alia, Quality Assurance, Finance, Regulatory , Clinical Supplies and legal in a… 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...other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director. Works with personnel… more
- Insmed Incorporated (Bridgewater, NJ)
- …contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we...and Clinical / Regulatory strategy.Author nonclinical sections in … more
- Merck & Co. (North Wales, PA)
- …for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical ... Writer:Demonstrates independence in preparing clinical regulatory documents (eg, protocols, clinical study reports, investigator's brochures, clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, ... 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
- Merck & Co. (Rahway, NJ)
- … clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be ... (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary Assist in planning… more
- Merck & Co. (North Wales, PA)
- … clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may ... talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of ... university)PhD in pharmacology or pharmaceutical sciences or PharmD with a clinical pharmacology research fellowship required Experience Qualifications7 or more… more
- Merck & Co. (Rahway, NJ)
- …efficiency, and productivity across the organization. Keeps abreast of project management, clinical data standards, and regulatory requirements for clinical ... Job DescriptionPosition Description: Manager, Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global Clinical … more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory , Statistical Programming, Data Management, and ... planning, providing guidance to others in the statistical support for clinical drug/vaccine projects.-Interacts with Academic Research Organization (ARO),… more
- Merck & Co. (Rahway, NJ)
- …, Regulatory , Statistical Programming, Data Management, and other Company Research Laboratories Scientists in designing and analyzing clinical trials, and ... in coordinating the statistical activities for clinical drug/vaccine projects.Interacts with Academic Research Organization (ARO), Contract Research … more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical R&D.--Collaborate with people from diverse background and expertise, including research scientists, clinical scientists, regulatory experts, ... and written reports.-Provide responses to data and analysis related queries from research scientists, clinical scientists, and regulatory agencies.--Engage… 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
