- Merck & Co. (North Wales, PA)
- …as well as the scientific communication platform and lexicon for products that they support . The Associate Director Pub Manager provides the Publication Team and ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central...in publication managementUnderstanding of the clinical development process andclinical study data for assigned projects.-Understanding of the scientific and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in planning and execution of clinical studies , under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project… more
- Merck & Co. (Rahway, NJ)
- …Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager's (CRMs) and/or TA-Head/CRD, this role is ... requirements internally and externally.The aCRM could be responsible for a particular study for a country or a cluster.Responsibilities include, but are not limited… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant regulatory requirements. This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry ... DM activities and deliverablesEstablishes Data Management strategy at the project and/or study level for a larger number of projects/ studies with greater… more
- Merck & Co. (North Wales, PA)
- …Reporting Tool (SMART) and others if needed- and the Supplier system) in order to support generation of- study KRIs and Quality Tolerance Limits (QTL)s out of ... Under the oversight of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the integration between our source systems (primarily Data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … support SMTs, SERM or other safety-related meetings and study protocols.This position independently manages relationships with internal (CSPV, Regulatory, ... support planning for epidemiology strategy for assigned products.RESPONSIBILITIESIdentify study needs, draft protocols, and contribute to epidemiology strategy… more
- Aequor (South San Francisco, CA)
- …process involves closely collaborating with scientists across the organization to support the overall safety assessment for our Client therapeutics spanning drug ... As such, we are constantly establishing new platforms and technologies to support a constantly changing portfolio, Client modalities, and emerging therapeutic area… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies . Partner with Project Management, Clinical ... global business partners to develop budgets and analytics for ongoing and new pipeline studies in support of the annual process of extracting the optimal value… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Change Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. ... opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility ... team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines, government… more
- Merck & Co. (Rahway, NJ)
- …eg generating and evaluating data). Conduct residue chemistry and metabolism studies to support domestic and international registration of pharmaceuticals ... monitoring, reviewing and/or summarizing residue chemistry, metabolism and bioanalytical studies to support domestic and international registration of… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related ... trials including functional services.Accountable for vendor management; providing guidance to study teams on vendor selection and management options in alignment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director, Global Strategy & Investigations Owner/Lead as part of the ... Key Responsibilities Additional responsibilities include; Provide technical leadership and support to an expanding global manufacturing network for best-in-class… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and non-clinical studies used to inform gaps in knowledge to support improved understanding of disease/drug mechanisms to support QSP model ... areas centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative… more
- Merck & Co. (Rahway, NJ)
- …and manufacturing to advance the biologics pipelineConduct laboratory-scale and/or pilot-scale studies to support scale-up and tech transfer of ... Job DescriptionBiologics Process R&D Associate ScientistOur Research Scientists are our Inventors.- Using...engineers to design, develop and execute robust processes in support of early- to late-stage biological products. You will… more
- Novo Nordisk Inc. (Atlanta, GA)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... strategically and initiates strong and persuasive contractual arguments to support business policies and objectives Performance monitoring: Tracking key performance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming ... projects, act as statistical programming subject matter expert (SME) to support outsourced programming activities and be responsible for the programming technical… more
- Merck & Co. (North Wales, PA)
- …the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve as the liaison and manages correspondence with… more
