- Merck & Co. (Rahway, NJ)
- …issues, mitigation plans and value realization. Partner closely with IT and its Program Management to ensure alignment across planning and investment.-Set up, ... scientific-related discipline strongly preferredRequired Experience and Skills:--Research, manufacturing, and project/ program management experience in pharma Demonstrated ability… more
- Merck & Co. (Rahway, NJ)
- …of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned ... scientific and clinical research knowledge is required. Strong understanding of clinical trial planning, management and metrics is essential as well as… more
- Novo Nordisk Inc. (Los Angeles, 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
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will ... collaborate with global, cross- functional team-members including clinical directors and study managers to lead/support clinical trial scientific-activities.Job… more
- Merck & Co. (Rahway, NJ)
- …and mentoring to the CTCs, as well as for interns-delegated to the Clinical Operations team based on the Internship program , while-properly managing situations ... or higher) with a strong emphasis in science and/or Clinical Research Management /Administration.#MRLGCTO#eligibleforERPNOTICE FOR INTERNAL APPLICANTSIn accordance… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Specialist position is a combined position of clinical scientist and study management duties supporting one or more clinical ... trials. Under the oversight of a clinical scientist, study manager, or program lead, the Clinical Specialist may be responsible for but not limited to:Job… 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
- 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
- Merck & Co. (North Wales, PA)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management , regulatory agencies, or… 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
- 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. (Boston, MA)
- …community, research conducted in our laboratories spans exploratory biology through early clinical development and is an integral part of our company's powerful ... pharmaceutical science and drug delivery research from target identification through clinical candidate selection for both small and large molecules.DPS influences… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to...analytic support to the field team, and assists the Program Development and Training function for the TA. SD… more
- Merck & Co. (North Wales, PA)
- …& team processes and PM skills.Primary Responsibilities: -Portfolio and Project Management (~50%)Responsible for aggregating individual program information to a ... Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development...portfolio viewEstablish robust CMC and clinical stakeholder interfaces to maintain a pulse on all… more
- Merck & Co. (Rahway, NJ)
- …and other IT groups to establish shop-floor/lab-floor networks. -Implement a lifecycle management program for shopfloor and lab computer systems. -Develop a ... and aspiration of our Company's digital (Chemistry, Manufacturing, and Controls) CMC program to set the foundation for a digital continuum from development to… 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)
- …therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the ... pharmacokinetics (PK) and pharmacodynamics (PD) analysis, model-based meta-analysis (MBMA), clinical trial simulations (CTS), disease progression modeling and Artificial… more
- Merck & Co. (Rahway, NJ)
- …analy sis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities include: - Driving solutions to analytical ... well as methods for the re lease and shelf-life assessment of clinical supplies under good manufacturing practice (GMP) settings. - Providing analytical leadership… more
