- Merck & Co. (Rahway, NJ)
- …the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development will focus on driving strategy , development , and life-cycle ... the late development of assets within the Metabolism Section of Global Clinical DevelopmentMay serve as a senior therapeutic area content expert within the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will ... collaborate with global , cross-functional team members including clinical directors and study managers to lead/support clinical trial scientific activities… more
- Merck & Co. (Rahway, NJ)
- …and monitor performance across our portfolio, studies & processes within Global Clinical Trial Operations (GCTO).Primary responsibilities include but are ... and reports to measure operational performance.-Defines release training and communication strategy .- Coordinates development and delivery of training and… more
- Merck & Co. (Rahway, NJ)
- …Ophthalmology.Primary Responsibilities:Lead the development and execution of the Global Marketing Strategy for the Ophthalmology Franchise.Drive launch ... of our key products is currently in Phase 2b/3 clinical trials for the treatment of diabetic macular edema....commercial input on activities such as target product profile development , global regulatory filing strategy ,… more
- Merck & Co. (Rahway, NJ)
- …- The position will require: Outstanding leadership in market assessment, disease state strategy , product clinical development , product strategy , market ... Leader engagement execution, competitive strategy , target product profile development , health authority interactions, global regulatory filing strategy… more
- Merck & Co. (Rahway, NJ)
- …Director, Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy for their ... global point of contact on those projects.Develops global regulatory strategy for their assigned products,... experienceM.D. with minimum of 3 years relevant drug development experience or clinical experiencePhD/PharmD with minimum… more
- Merck & Co. (Rahway, NJ)
- …DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy , Design Controls and Risk Management Our company's ... projects.-Lead the implementation and/or ensure effective execution of the device development strategy , design controls and risk management activities for… more
- Merck & Co. (Rahway, NJ)
- …Description: Associate Director, Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the ... direction of the Program Lead, you will collaborate with global , cross -functional team members including clinical directors and study managers to lead/support … more
- Merck & Co. (Rahway, NJ)
- …and relevant FDA guidelines Possess strategic experience in operational control strategy development and execution. Demonstrated ability for taking initiative, ... Job DescriptionThe Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for...technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate… more
- Merck & Co. (Rahway, NJ)
- … development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, ... components for our research pipeline.- This research opportunity contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable which is the… more
- Merck & Co. (Rahway, NJ)
- …hypothesis-based assessment employing a rigorous integrated approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio... with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong… more
- Merck & Co. (Rahway, NJ)
- …PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy for their ... interact with Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more company… more
- Merck & Co. (Rahway, NJ)
- …expected to collaborate with our Research & Development Division colleagues from Global Clinical Development , the Center for Observational and Real-World ... clinical trial program, as well as select early-stage development projects and other of our Research & ...Medicine, Global Medical and Scientific Affairs, and Global Regulatory Affairs and Clinical Safety to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, ... This position (GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are tracked and ensure implications are assessed and communicated on timely manner- Clinical Development Life Cycle Management Decision Support: Be the key point ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...launched brands. The role will be responsible for the development and maintenance of Short to Long Term Forecasts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Standards is responsible for the development and sustainability of the Global Clinical Data Standards for quality submissions and success of the Daiichi ... the appropriate levels of the Standards framework.Participate in review of Protocols, Global Clinical Libraries, Standards package, etc. to enhance efficiencies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy : Provides the strategic ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...from a medical strategy standpoint to the development of clinical sections of study-level documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for ... consistency and compliance across clinical study safety reporting and activities. Global Clinical Study Start-Up Documentation: Reviews all clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the fabric of Daiichi Sankyo.Responsibilities- Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC ... disease strategy and the strategic choices for clinical development and data generation- Develop and...or leading change management initiatives preferred- Prior experience in clinical development , Medical Affairs, or Global… more
