- Merck & Co. (North Wales, PA)
- …risks, proactively addressing issues that may impact project timelines, scope, or quality . Develop contingency plans and ensure risk mitigation strategies are ... Job DescriptionThe Senior Director , GCTO Project Management Office will report to...delivery of projects on time, within budget, and meeting quality standards. You will play a critical role in… 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)
- …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
- 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
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Cardiovascular (Cardio-renal disease & Heart Failure) will be responsible for overseeing and facilitating research in ... at a new state-of-the-art center in South San Francisco, CA. The Executive Director will contribute to the design, prioritization, and execution of the strategic… 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
- Merck & Co. (Rahway, NJ)
- …risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… 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
- 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
- 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
- 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. (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
- 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
- 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
- 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
- Catalent (Manassas, VA)
- …accordance with templates and liaise with site and Suppliers to finalize to allow Supplier Quality Director approval Act as a liaison between suppliers and the ... Senior Quality Auditor Position Summary: Catalent is a global,...Pre-Audit Preparation activities with an understanding of requesting sites risk assessment to ensure alignment to Global Standards Ensure… more
