- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Associate Director , Healthcare Quality Improvement is a role within the Global Professional Relations and Independent Medical ... and engagements with professional medical societies on ways to improve healthcare quality and guideline-concordant care.The Associate Director , Healthcare … 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Merck & Co. (Rahway, NJ)
- … Principal Scientist - Device Engineering and Early Development Lead ( Associate Director Equivalent)Our company's Device Development (DD) Team designs, ... technical device development team(s) supporting individual drug assets currently in clinical development with line of sight to commercial filing and launch.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager throughout all phases of ... with CRA Manager, CRM ( Clinical Research Manager, TA Head and CRD ( Clinical Research Director ) as needed.Works in partnership with GCTO (Global Clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA ( Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager-throughout all phases of a ... with CRA-Manager, CRM ( Clinical Research Manager), TA Head and CRD ( Clinical Research Director ) as needed.-Works in partnership with GCTO (Global … more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... automation activities throughout the facility.-Primary Responsibilities:Provide process support for clinical manufacturing and R&D processes while also facilitating tech… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... collaborate with CROs ( Clinical Research Organizations) and manage oversight. The position will partner with internal and external stakeholders to optimize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, development ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/ Associate Director , External Manufacture as part of the Global Manufacturing ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
