- Spectraforce Technologies Inc (Alameda, CA)
- Job Title: Clinical Research Associate - B Location: Alameda, CA (94502) Shift - 8:00am to 5:00pm Duration: 6 Months with possible extension Payrate starts at ... to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing...Experience: 3-5 Years Experience Level Team Overview: Have 2 clinical managers and 2 study leads. They… more
- Insmed Incorporated (Bridgewater, NJ)
- …delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple ... specific, drug, program, and therapeutic area level), and maintains training matrices for the clinical study team.Actively participates in clinical study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... documentsServes as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and can conduct/develop PK-PD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... Budget; Establishes effective communication between CRO / vendors / AROAdditional non- study related activities: Occasional senior management interactions at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document… more
- Merck & Co. (Rahway, NJ)
- …business.Under the guidance of the Clinical Development Finance Associate Director, the Finance Senior Specialist will:Provide financial planning, ... Division Oncology Clinical Development.Forecast grant spend related to Oncology clinical studies , as well as providing financial support related to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Merck & Co. (Rahway, NJ)
- …standards development teamsThe Vocabulary Specialist maintains knowledge of new technologies, clinical study data standards, regulatory requirements emerging in ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr . Associate OpEx Engineer as part of the Technical Operations team based ... for providing operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead… more
- Merck & Co. (North Wales, PA)
- …the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your ... management, communication, and collaboration skills in support of our clinical trials. Job Responsibilities Responsible for the operational planning, feasibility,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies . Partner with Project Management, Clinical Operations and other ... Effectively uses and communicates key findings and presents recommendations to Senior Regional and Global Finance Leaders.- Annual Portfolio Prioritization -… more
- Insmed Incorporated (Bridgewater, NJ)
- …while adhering to corporate policies and external regulations and guidance. The Senior Manager, Scientific Communications & Publications, provides support to the ... Associate Director/Director for the development and execution of the...include research and development, health economics and outcomes research, clinical development, marketing, biostats, corporate communications, and medical affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to or independently leads the design, preparation and analysis of epidemiologic studies , including real-word evidence (RWE), supporting senior management in ... areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clearance, supply / device management) Responsible to ensure timely availability of clinical study materials and ancillary supplies to North America distribution ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo... Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and ... access strategy for the assigned oncology asset(s). This person will report to the Sr Director, Global Oncology Value Pricing & Access, and will be responsible for… more
- Novo Nordisk Inc. (Boulder, CO)
- …Plan, manage & perform validation activities at the Boulder Pilot and Clinical GMP Plants. Handle simple to moderate complexity validation projects. Support ... SOPs, IQ, OQ, PQ, design documents, final reports, cleaning studies , facility validation, computer validation, temperature mapping, audit support, CAPA,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates...product labeling as it relates to the use of study results in US promotion.Maintain current awareness of evolving… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure that the most up-to-date information on the therapeutic area and NNI clinical plans and study results, product support letters, and the Marketing and ... and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant...review, initiation, and completion, as well as publication of study results. Provides clinical support in cooperation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts frequently in ... collaboration with internal management and senior level global stakeholders Interacts internally with Strategic Pricing...strategy for all pipeline products starting in Phase II clinical trials. Generates insights to support G3 decision-making for… more
- Daiichi Sankyo, Inc. (Nashville, TN)
- …informationIdentifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) ... research, academic or US managed markets preferredPrevious experience in Oncology, clinical research and medical education preferred Principal MSL/ Associate … more
