- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for...and to create value for patients and the healthcare system .Responsible for maintaining high level of visibility of operational… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...with our Company IT leadership to develop a long-term systems and capability strategy and to prioritize DSCS Digital… more
- Merck & Co. (Rahway, NJ)
- …and demonstrated experience in Facility, Equipment, Instrument, and computer system validation.Experience with aseptic processing operations such as ... (include Requirements For Education, Experience And Skills)Job Description:The Associate Director Quality Assurance, Facilities, Validation & Automation will provide… more
- Merck & Co. (Rahway, NJ)
- …role of Associate Director . The team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems… more
- Merck & Co. (Rahway, NJ)
- …work to design, install, and qualify new equipment to support GMP clinical production. -Execute and develop appropriate system validation, change control, ... on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot… more
- Merck & Co. (Rahway, NJ)
- …to support the Animal Health division. The position reports to the Director , our company's Outcomes Research.Position objectives: To inform and contribute to the ... value evidence strategy and associated studies which describe clinical , economic, and patient-centered unmet needs and the value the product provides in addressing… more
- Merck & Co. (Rahway, NJ)
- …and mentoring to the CTCs, as well as for interns-delegated to the Clinical Operations team based on the Internship program, while-properly managing situations ... and procedures and-with quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director ) / Director , Clinical … more
- Merck & Co. (Rahway, NJ)
- …according to quality, compliance and timeliness requirements; expertise in SAS and clinical trial programming, systems and databases including advanced knowledge ... and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to… more
- Merck & Co. (Rahway, NJ)
- …with the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Operations Specialist ... experience and a strong understanding of engineering fundamentals. The MACS Operations Specialist position will report to the Director , Engineering and… more
- Eisai, Inc (Nutley, NJ)
- …unlawful actions.Oversee system data retention standards and verify system operations .Manage Eisai's information governance program, including JSOX ... Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the...System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information Systems Auditor… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations . Essential Functions Work with ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… more
- Merck & Co. (Rahway, NJ)
- …execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure.- ... responsibility. The Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the… more
- Eisai, Inc (Nutley, NJ)
- …describe complex disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of interventions beyond ... Requirements: A postgraduate degree such as Masters, MBA, PhD in Operations Research, Mathematics, Economics, Engineering, Biostatistics, MD, PharmD or a similar… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... (eg, CRO); oncology, immunology, or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus… more
- Merck & Co. (Rahway, NJ)
- …project management responsibility. The Specialist -Engineering position will report to the Associate Director , Engineering and will be a member of the EF Team at the ... interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring new technologies. -… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Principal Scientist - Device Development Lead ( Director Equivalent) Our company's Device Development (DD) Team designs, develops, ... and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing,… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non- clinical ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
