- Merck & Co. (North Wales, PA)
- … Clinical Trial Operations (GCTO). The role will also contribute to the Program Management Office (PMO) tracking and reporting, change management strategy ... Job DescriptionPosition Description: Director, Global Clinical Trial Operations (GCTO) Project Management ...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level or senior director level, depending on the scope and size of the asset program . This Clinical Science (CS) lead will be responsible for leading and ... managing one or more clinical scientists, oversee a program of ...science lead will also participate in the creation and management of new clinical science group from… more
- Novo Nordisk Inc. (Irvine, CA)
- …strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North… more
- Insmed Incorporated (Bridgewater, NJ)
- …highly strategic view is required. This opportunity will require a focus on all the clinical aspects of the upcoming HS program . Strong leadership skills are a ... amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(short-term, mid-term, long-term)These will include but not limited to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical ... to end in collaboration with GCLs, Physician Scientists and the study team (data management , clinical operation and other functions) to implement clinical … more
- Eisai, Inc (Nutley, NJ)
- …and/or consultants. Contributes to management of key portfolio and program management managed service providers including financial management ... environment and developing procedures for successful implementation.Americas IT Portfolio / Program / Project Management Office Services and Operations… more
- Merck & Co. (North Wales, PA)
- …support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management , and our ... of clinical trials to the project team, our company's Management , regulatory agencies, or individual investigators.Provides responses to queries relating to… more
- Merck & Co. (Rahway, NJ)
- …process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical and ... ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key company functions.Represent Device… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... site feasibility assessment from a physician's perspective- May provide clinical input into the eCRF ( Case Report...management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program … more
- Novo Nordisk Inc. (Las Vegas, NV)
- …to gain access and drive business impact by collaborating around the clinical management of patients and offering NNI-approved solutions Demonstrates ... and legal requirements. Manages discretionary territory budget and marketing promotional program budget to support territory sales goals Demonstrates a clear and… more
- Merck & Co. (Boston, MA)
- …of the Common Technical Document (CTD) and label, including relevant compound/ program life-cycle management .The successful candidate will have an essential ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early … more
- Merck & Co. (Rahway, NJ)
- …of the Common Technical Document (CTD) and label, including relevant compound/ program life-cycle management .The successful candidate will have an essential ... Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early … more
- Merck & Co. (Rahway, NJ)
- …work that includes direct project support of the current our Company's clinical pipeline and prospective technology development that enhances our ability to deliver ... for working closely with their counterparts across Development Sciences and Clinical Supply (DSCS), Discovery, Preclinical and Translational Medicine (DPTM), and our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …throughout the US affiliate and globally if needed; responsible for administrative and management support of field-based FMA Program at Novo Nordisk Inc (NNI). ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...all laws, regulations and policies. Responsible for administrative and management support of field-based FMA Program at… more
- Merck & Co. (Rahway, NJ)
- …in 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...supporting the QP2-I/O Function Lead on oncology development teams.Data management and analysis.On the job, working with senior scientists… more
- Merck & Co. (Rahway, NJ)
- …Elastic Compute Cloud (Amazon EC2), Business Administration, Business Communications, Business Management , Case Development, Client Management , Cloud ... problems or derive benefit to the company AI capabilities and generative AI program , Conduct feasibility studies and create working proof of concepts for use-cases… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Merck & Co. (Rahway, NJ)
- …and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process developmentA strong ... transfer of assays. Plan assay optimization and documentation to meet program deadlines.Authoring and reviewing internal technical reports, sections of regulatory… more
- Merck & Co. (North Wales, PA)
- …strategies and plans for developmental compounds and obtains cross-divisional senior management approval Critically assess drivers and barriers to reimbursement and ... access and identify value evidence needs to provide strategic input into clinical and market development programs. Bring strong payer and HTA/reimbursement focus… more
- Merck & Co. (Rahway, NJ)
- …technology evaluation and shaping scientific strategy both at the platform and program level.Project management and/or scientific over-sight of work outsourced ... responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and promotion planning). Maintaining a… more
