- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical ... and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …procedures, quality , and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role will interface ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation ... position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is...the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with … more
- Genmab (Plainsboro, NJ)
- … you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In addition, ... essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …industry with management experience At least 5 years of experience as a Clinical Trial Manager Experience with global clinical trial operations, ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ... systems and services. In this position, the GSM will lead major incident calls, conduct problem management meetings, and...on the global performance of owned processes. Monitor Service Quality and put proactive measures in place to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure...safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug… more
- Merck & Co. (Rahway, NJ)
- …compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or ... Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... support patient services initiatives. Relationships Reports to Consumer Experience Lead . Collaborates with key external and internal cross-functional teams,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …help drive process improvement and efficiencies for the Medical Information team. The Senior Manager will also serve as the onboarding lead for the Medical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP CX Manager -CV/Renal will be a critical driver in ensuring the successful execution of brand/therapy ... and marketing execution. Relationships Reports to HCP KOL Strategy Lead -CV/Renal. Collaborates with key external and internal cross-functional teams, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a... Assurance oversight and support for all phases of Clinical and Production documentation and processes Knowledge, Skills, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, ... for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- clinical , Medical Affairs, Marketing, Legal, Quality , and other ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- One Medical (Rochelle Park, NJ)
- …needed In partnership with with Clinical Leadership and the Operations Manager , support quality health outcomes, patient safety, regulatory compliance, and ... care solution challenging the industry status quo by making quality care more affordable, accessible and enjoyable. But this...the primary care experience, we're looking for a Team Lead (internally known as a Practice Coordinator) to join… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The **Senior Manager Clinical Study Lead ** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of ... assigned large and/or complex clinical trials from study design, through execution, to study...drug reconciliation + Escalates issues related to study conduct, quality , timelines or budget to Program Operations Leader (POL)… more
