- Merck & Co. (Rahway, NJ)
- …effective CAPA management solutions.Has worked with risk management tools and processes within the clinical quality framework.Skills:Superior oral ... for, management and follow up of regulatory inspections.Operational Quality Management :The Clinical Quality Operations Manager is accountable for… more
- Merck & Co. (San Diego, CA)
- …status update reports, study close out activities).-Leads team for timeline management , risk identification and mitigation, issue resolution.-May facilitate and ... PowerPoint, Word, Outlook, etc.)Education/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management , and/or medical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …its application to drug development required to deliver time, cost, quality, and risk management to teams.Demonstrated results in creating and managing complex ... Role OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to drug product manufacturing required to deliver time, cost, quality, and risk management to teams.Experience with Healthy Authority requirements and regulatory ... myeloma.Legend Biotech is seeking a Strategic Initiatives & Capacity Expansion Project Manager as part of the Technical Operations team based in Raritan, NJ.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… more
- Merck & Co. (Boston, MA)
- …Development Sciences (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services ... more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- …Performance Indicators (KPI), Management Process, Materials Requirements Planning (MRP), Project Management , Risk Management , Supply Chain Systems, Team ... to participate in development of tools and processes to support holistic portfolio management and increased integration of CMC and Clinical strategies. Position… more
- Merck & Co. (North Wales, PA)
- …options, documentation; risk -benefit analysis techniquesWorking knowledge of eTMF and Clinical Trial Management systems21 CFR Part 54 Financial Disclosure ... IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Asset Life Cycle Management , Audits Compliance, Clinical Information Systems, … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C...ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management … more
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