- Northeast Georgia Health System, Inc (Gainesville, GA)
- …and sub-projects of larger programs. Uses a variety of PMO tools to develop project scope and charter, create project plans, assign and manage resources, plan ... implement IT projects, and communicate status and progress to leaders and project teams. Oversees all aspects of projects, including scope, work breakdown… more
- Merck & Co. (Rahway, NJ)
- …DescriptionPosition Description: Manager , Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global Clinical ... in quality, efficiency, and productivity across the organization. Keeps abreast of project management, clinical data standards, and regulatory requirements for … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Efficiency / Continuous Improvement:Provides comprehensive data management expertise to project /study teams to optimize study-specific clinical trial ... immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors… more
- Merck & Co. (Rahway, NJ)
- …company Standard Operating Procedure (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP.)As line manager , the role is critical ... will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical...capabilities. The role will collaborate with country Partner Line Manager 's ( PLMs) to ensure alignment across all monitoring… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division ... organization of our company.- Position Description/Summary: The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late… more
- Novo Nordisk Inc. (San Antonio, TX)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Aequor (NJ)
- …of supplies to study participants. Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and ... 100 % remote Manager prefers local candidates (will consider non local...Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial experience Managing end to end supply chain… more
- Merck & Co. (North Wales, PA)
- …objectives. Minimum education required: Bachelor's Degree +2 years of pharmaceutical, clinical drug development, project management and/or medical field ... experience.OR Master's Degree +1 year of pharmaceutical, clinical drug development, project management, and/or medical...to have a minimum of twelve (12) months of service in current position prior to applying for open… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical... Safety, CROs and External Vendors for the data services they provide to support drug development processes and… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Catalent (Harman, WV)
- …shift consisting of Warehouse Materials Control Associates and Materials Services Associates. Responsibilities include: project participation, dashboarding, ... Job Description: Manager , Supply Chain - WarehouseThe Manager ,...distribution.Ensure that all activities follow GMP regulations.Ensure that all project work is managed under GMP Change Control where… more
- BioAgilytix (Durham, NC)
- The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects including new products and life cycle management. This includes ... product submissionsPrepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory agenciesCoordinates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in support of the established… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the ... business partners and external agenciesPotentially Lead or Co-lead cross-functional project teams involving Marketing, Sales, Managed Markets/Market Access, Legal,… more
- Catalent (St. Petersburg, FL)
- …to Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service , with the highest integrity, focused on ... QA Product Manager Position SummaryThe QA Product Manager ...analysis to eliminate future problems. Participates in Product Development/Validation/Engineering project meetings to provide Quality Assurance input with respect… 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 ... Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services (GBS), PV & GDP Auditor(s) as well as...major programs or initiatives, and may function in a project leadership role Regulatory compliance: Ensures compliance with all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager /Associate Director, External Manufacture as part of the Global Manufacturing Supply ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …industry trendsProspect for new accounts and business that would benefit from Lovelace services by geography, service platform or stage of growth. Present ... OverviewUnder the direction of the Senior Director of Non- Clinical Drug Development and with limited direction, the...Drug Development and with limited direction, the Business Development Manager will be responsible for sales and marketing support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the Technical ... be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... External Vendors for the data services they provide to support drug development processes and...all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development,… more
