- Merck & Co. (Rahway, NJ)
- …of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product. Additionally, experience in medical ... objectives utilizing external contractors including GMP qualification as well as site/ project selection.- Additionally, the incumbent would serve as the bridge… more
- Merck & Co. (Rahway, NJ)
- …The FLEx Co-Lead role is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research ... Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical … more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Manufacturing Automation position ... will report to the Director , Engineering, Automation Lead position and will be a...production, utility systems and associated infrastructure.- Responsibilities of the Associate Specialist - Manufacturing Automation include the following: Small… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...and oversee completion of clinical trial protocols. Provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP...address prioritization across the portfolio within Oncology/Immuno-OncologyCollaborate with multidisciplinary project teams to develop and apply QSP models to… 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 ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies. ... Develops and maintains a working relationship with the internal project team(s) and team leader(s) or US based Global...to the Global Team Lead (GTL) and GPT (Global Project Team) for the control and reporting of approved… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... protocols.This position independently manages relationships with internal (CSPV, Regulatory, Clinical , Medical Affairs, HEOR and other stakeholders to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...decision-making with management Demonstrated track record of portfolio and project management, with the ability to work across all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will ... and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position ... Finally, this position has strong skills in continuous improvement, project management, change management, and risk management. ResponsibilitiesLeadership, Direction,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interfaces within a matrixed environment and with varying professional levels Leads Clinical Ancillary Management project teams to ensure Clinical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts frequently in ... scenarios and strategy for all pipeline products starting in Phase II clinical trials. Generates insights to support G3 decision-making for the NASH franchise… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HEOR is a significant contributor to the development ... and communication of HEOR evidence to demonstrate the value of Insmed's product(s). The Associate Director will work closely with HEOR team members and others… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... understanding of advanced statistical concepts and techniques applicable to Clinical ResearchExcellent project management, interpersonal and communication… more
