- 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
- 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)
- …- Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase ... I-III clinical studies.Partner with Project Management, Clinical Operations and other functional groups to ensure budgets...Budget Planning - Manages and is accountable for the development and control of functional budget in support of… 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
- 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)
- …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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development , Clinical Scientists, Clinical ... integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... clinical trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity,… more
- Merck & Co. (Rahway, NJ)
- …Oncology medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... diseases. --The Director will report to an Associate Vice President in the Oncology Clinical ...affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Senior/Executive Director /AVP… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... development process & connectivity between functions supporting pipeline (ie clinical development , Compound Management Coordination , supply chain, & human… more
- Merck & Co. (Rahway, NJ)
- …of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related ... effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will...Serving as an expert representative for QP2-IO on Oncology clinical development teams. Framing critical questions for… 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
- 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
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... collaboration with the Global Regulatory Lead(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. You… 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
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... single or multiple clinical trials from strategy outline through to CSR by...regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development and management of the trial budgetPlan, implement, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
