- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and teams)Support regional representatives in collecting, analyzing, and synthesizing key regulatory intelligence in a systematic mannerEstablishes a database ... Policy activities in one or more regions (USA required), incl. maintaining a database of regulatory intelligence and coordinating engagement with industry trade… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …recognize and respond to changing internal and external trends, market conditions, regulatory legislation, etc., evaluate and integrate the information to define ... team cohesion, assures rapid communication and best practice sharing with peers/ management .Prospectively functions as a conduit of information between the… more
- Merck & Co. (Rahway, NJ)
- …for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management , and other company ... communicate results of clinical trials to the project team, company Management , regulatory agencies, or individual investigators.Provides responses to queries… more
- Merck & Co. (North Wales, PA)
- …position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across the ... patterns and disease progression, answer clinical development questions, and support regulatory submissions.- In this role, the principal statistical programmer will… more
- Merck & Co. (North Wales, PA)
- …projects under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other of our ... effectively communicate results of clinical trials to the project team, management , regulatory agencies, or individual investigators.Provides responses to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... of deviations, events and key process parameters and provides reports to management on trending, and status as requested. Identify and implement process improvements… more
- Merck & Co. (Durham, NC)
- …multi-stage refrigeration systems) Required Experience and f amiliarity of regulatory requirements in accordance with GMP manufacturing operations Preferred ... the biopharmaceutical fieldExperience with GMP compliant calibration and/or maintenance database systems.Knowledge of SAP and DeltaV and Procal.Physical Requirements:… more
- Merck & Co. (North Wales, PA)
- … expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine regulatory application ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Insmed Incorporated (Bridgewater, NJ)
- …Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level medical oversight of information ... of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies.Must have a… more
- Merck & Co. (Durham, NC)
- …to function in a team-based empowered culture - Seeks ideas and information on how to improve customer service involving internal and external customersApplies ... equipment, completing validation protocols, documenting work using a computerized maintenance management system and other duties as requested by the Utility… more
- Merck & Co. (Durham, NC)
- …empowered culture but perform successfully as an individual. Seeks ideas and information on how to improve customer service involving internal and external ... This individual will partner with Quality Operations (QO) Lab Plant Engineering Management as well as the respective lab managers to provide equipment services… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Rahway, NJ)
- …including proportional hazards models.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...or other applicable legally protected characteristics. - For more information about personal rights under the US Equal Opportunity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate skills ... in database and research tools.ResponsibilitiesSupport the Head Global QA strategy...relevant activities including Business Plan, QQR, team building and management review.Involve and attend the Global QA relevant meeting… more
- BioAgilytix (Durham, NC)
- …to the design and implementation of projectsKnowledge of IT infrastructure and information database systemsAbility to learn new techniques, perform multiple ... are identified and address corrective actions as neededAssist during regulatory agency and sponsor inspectionsCollaborate with cross-functional teams to address… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into different functions of GMP QA Department such as Audit, Quality Management System, Pharma Product, External Supplier Management and Strategical Operations ... potential new metricsSupporting continuous improvement projects assigned potentially within regulatory compliance, internal/supplier auditing, or customer focus activitiesPerforming the… more
- Merck & Co. (Rahway, NJ)
- …members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and ... to: Microsoft Office (Word, Excel and Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems. Must be willing and able to lift 50 lbs, bend,… more
- Everglades Equipment Group (Wellington, FL)
- …of a team in a fast-paced environment. Strong organizational and time management skills. Ability to maintain confidentiality and handle sensitive information . ... Even tempered and non-bias character is a must Ability to use database software and human resources computer application systems Understanding of confidentiality… more
