- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global … more
- Merck & Co. (Rahway, NJ)
- …activities involving investigational compounds in Immunology. With a focus on late-stage development , the Executive Clinical Director will manage the ... the development of new compounds The Executive Clinical Director may: Oversee the clinical...in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects Assist the Associate… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core...MBA, Ph.D., PharmD) preferred - Experience and knowledge of clinical drug development strongly preferred; including the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Merck & Co. (Rahway, NJ)
- …by leveraging digital, data, and analytics to measure our organizational impact.The Associate Director , Global Oncology Commercial Pipeline Analytics, HHDDA will ... making and increase commercial rigor through all phases of alliance asset development .Reporting to the Director of Global Commercial Pipeline Analytics, the… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the ... the development of new compounds The Senior Clinical Director may: Oversee the Clinical...affairs, statistics, and manufacturing to manage clinical development projects; and assist the Associate Vice-President/Vice-President… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Merck & Co. (Rahway, NJ)
- …control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ... Working Groups to ensure full integration of the device development activities with the clinical , regulatory, formulation,...of the device development activities with the clinical , regulatory, formulation, commercial and other key of our… more
- Merck & Co. (Rahway, NJ)
- …driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report ... development with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong influencing and communication… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... with small molecules, biologics, and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol … more
- Merck & Co. (Rahway, NJ)
- …affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Associate Vice President in ensuring ... and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& ManagementOversight of Data Request processing by Service ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and ... 8.0.x and 7.0.x Patches.Experience with SQL programming/querying, custom report design/ development from Argus Safety backend database.Strong knowledge of Oracle… more
- Merck & Co. (Rahway, NJ)
- … Development Team, Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides a solid ... team of TA dedicated global and regional directors and associate directors. The Executive Director , Value &...least 5 years global or US medical affairs or clinical development experience with proven track record… more
- Insmed Incorporated (New York, NY)
- …healthcare influencers.Full support and execution of Medical Affairs plans, Clinical Development projects, programs, and initiatives.Job Requirements:An advanced ... synthesize and deliver HCP derived scientific insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations, and Medical… more
