- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: ... regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project ;...Program related: Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight: ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine...for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the… more
- Merck & Co. (Rahway, NJ)
- …design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of a physician (Global Clinical Leader or Physician Scientist). The clinical science lead will also participate in the creation and management of new ... and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The CS lead will...incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader (GTL),… more
- Merck & Co. (Rahway, NJ)
- …are deployed in support of clinical trials. The candidate for this Senior Principal Scientist and group lead position should have extensive technical ... matter expert in genomics-based assay development and validation, collaborating with project teams, biomarker leaders, companion diagnostics leaders, clinical … more
- Merck & Co. (Rahway, NJ)
- …development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.Proactively resolve ... your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with respect to device… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- … Outsourcing. Under the direction of the Sr. Director, Clinical Outsourcing, the Senior Manager, Clinical Outsourcing will lead and manage the ... of issues and conflicts.Supports organizational governance activities with vendors.Works with Project Teams to ensure outsourced clinical trial activities meet… more
- Merck & Co. (Rahway, NJ)
- …on-the-job training and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager. Your Fellowship ... more clinical trials. You will assist the Lead Clinical Scientist and study team with...& networking opportunities within and beyond CSSM Exposure to Senior level positions within the clinical development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …product development plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development ... supporting divisional and departmental level objectives and may also lead a non- project initiative in support of...execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high… more
- Merck & Co. (North Wales, PA)
- …technical writing, able to convert complex ideas and information into simple readable formA project leader ; completes tasks independently at a project level; ... external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.- Primary Responsibilities:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead ; supports Phase 2/3 ... of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on… more
- Merck & Co. (Rahway, NJ)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... in the late development of assets within the Respiratory Section of Global Clinical DevelopmentMay serve as a senior therapeutic area content expert within… more
- Merck & Co. (Rahway, NJ)
- …executing end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/ Lead Clinical Data Manager ... team-- - Benefits of Fellowship - Mentoring & networking opportunities within and beyond Clinical Trial Operations Exposure to Senior level positions within the … more
- Merck & Co. (Rahway, NJ)
- …in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Process/Facility Engineering position ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Process/Facility Engineer include the following:The process… more
- Merck & Co. (Rahway, NJ)
- …the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-Preclinical...in one of the world's most research-intensive biopharmaceutical companies. Senior Specialists in QP2-I/O-will work in collaborative teams with… more
- Merck & Co. (North Wales, PA)
- …analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)A project leader ; completes tasks independently at a project ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Essential Functions Support the VP Medical/Scientific Development as the US/international clinical lead for DCR-PHXC program to both internally and ... make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific...clinical development problems Work with the larger Global Project Team to deliver excellent medical support for DCR-PHXC… more
- Merck & Co. (North Wales, PA)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ... Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to ... the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance… more
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