- Tris Pharma (Monmouth Junction, NJ)
- …Fosters a culture of quality -by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue resolution, ... in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director ,... study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical ... into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical OperationsEnsure high quality delivery of all studies for… more
- Merck & Co. (Rahway, NJ)
- …are expected to independently execute on the following:Plans and facilitates high risk and highly complex Quality -related process reviews and/or investigations ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working ... 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. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of ... internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to provide strategy leadership in safety signal detection and evaluation, risk management, and post-marketing epidemiological safety studies required by Health ... and on the market through appropriate epidemiology studies. This Executive Director , the sub-functional lead for Epidemiology group in Global Medical Safety,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies… 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
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections,...substance and/or final drug product to support Phase I/II clinical trialsWork with clients during initial and subsequent manufacturing… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... but not necessarily be limited to, the following:Facilitate and maintain a risk -based and scientific-based quality system to support Good Pharmacovigilance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of… more
- Merck & Co. (Rahway, NJ)
- …2 years of management responsibility and experience developing staffFluency in the clinical quality management system and CMC process, across modalities and ... 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
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Director of Immuno-Metabolism will be responsible for overseeing and facilitating the research in metabolic disorders & inflammation, in the ... focus on uncovering novel biology in immuno-metabolism to deliver a high- quality drug discovery pipeline.We are a research-driven biopharmaceutical company. -Our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level and along the clinical trial process in support of a proactive quality risk management process. Interact with the audit function. The respective Data ... Plan together with the supported GPTs including the quality risk assessments and inspection readiness components...ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality … more
- Tris Pharma (Monmouth Junction, NJ)
- … management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to ... safety information updates, potential risks mitigation, etc. Collaborates with appropriate clinical , medical, quality and regulatory counterparts and others… more
- Merck & Co. (Rahway, NJ)
- …and clinical development leadership. Responsible for leading deep scientific and clinical due diligence, the quality of formal due diligence output, ... Job Description Position Description: Director , Business Development - Enabling Technologies Search and Evaluation Job The Search and Evaluation (S&E) team is a core… more
- Insmed Incorporated (Bridgewater, NJ)
- …In addition, the ED will be responsible globally for executing the safety and risk management activities for one or more clinical development or marketed ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team.… more
- Merck & Co. (Rahway, NJ)
- …to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and ... biopharma research, such as public Omics databases (eg, GenBank, GEO), clinical trial repositories (eg, ClinicalTrials.gov), patient-level data platforms (eg, OMOP,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Develop and ensure execution of an effective and efficient GOMA CoE Risk Management Plan (RMP) and support conduct oversight. Assess CoE compliance risks ... and operational support, in conjunction with key stakeholders (Legal, Compliance, Quality Assurance (QA) and Medical Affairs Subject Matter Experts) across… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/Associate Director , External Manufacture as part of the Global Manufacturing Supply team ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… more
