- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team ... global MSAT organization. This individual will be responsible for global process validation activities in support of the commercial Carvykti program both within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications solutions to meet business needs.Assemble ... implementation teams (including external vendors) in the design, development, implementation, validation , roll-out, training and support of global and regional DS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other strategic business initiatives.- Develop valuation model, including sourcing and validation of key assumptions and data from global cross-functional teams ... (Marketing, RD, Finance, Supply Chain, etc). Deal Valuation Analysis: - Lead analysis of financial analysis and models underpinning deal terms; analyze deal economics quickly to identify key value drivers and looks at key sensitivities. Preparation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.Drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth knowledge of regulatory authority's ... requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide career growth and provide development opportunity for statistical programmers. Manages contract statistical programming staff to… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Merck & Co. (North Wales, PA)
- …at the forefront of digital transformation in the biopharmaceutical industry. As a Director of Content Management, you will play a pivotal role in simplifying our ... other relevant software for quality management and training. Experience with Validation Management (KM) tools like Kneat. Preferred Experience: Experience with data… 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 ... and retain a diverse, talented team that delivers on target identification & validation and advances CMD pipeline.Education Requirement: PhD, MD, or MD/PhD degree in… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs that change ... drug product.Experience leading and/or interacting with GMP manufacturing, process validation , and tech transfer teams.Domestic and/or International travel required… more
- Fidelity TalentSource LLC (Westlake, TX)
- Job Description: Director , Software EngineeringRoleAs aH&W migration Director you blend strong Software Engineering knowledge with a passion for coaching, ... consequences of design.Develops and directs software system testing and validation procedures, programming, and documentation.Analyzes information to determine, recommend,… more
- Fidelity TalentSource LLC (Boston, MA)
- …consequences of design.Develops and directs software system testing and validation procedures, programming, and documentation. Education and Experience: Bachelor s ... field and six (6) years of experience as a Director , Front End Development (or closely related occupation) developing...Jenkins and SeleniumGrid -- by creating Jenkins jobs with validation for quality gates and security; building, deploying, and… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …About the Role:Job SummaryUnder the general direction of the Executive Director , Corporate Controller, responsible for the coordination of all CMS reporting ... Requirements: Masters degree or CPAPreferred Experience: Operational experience as a Director in a health systemOther: Job Specific and Unique Knowledge, Skills… more
- Fidelity TalentSource LLC (Merrimack, NH)
- …an equity compensation services division of Fidelity Investments, is seeking a Director of Software Engineering/ Technical Lead to help lead our Global Recordkeeping ... design. \u00A0\u00A0 \u00A0Develops and directs software system testing and validation procedures, programming, and documentation. \u00A0\u00A0 \u00A0Work with Product… more
- Rose International (Los Angeles, CA)
- …data and AI projects, including data acquisition, modeling, validation , deployment, and maintenance.Experience managing portfolios in Administration (Finance, ... on progress, health, risk (& remediation plans) directly to the PMO Director . From a project management standpoint, the PfM develops project charters, builds… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …adhered to, and documented. Reporting variances or deviations to Department Director and PI.Maintain strong working knowledge of Standard Operating Procedures ... logs, Adverse event (A/E) forms, memo to file, etc. Inform Program Director of variances or expected barriers.Plan, organize, and participate in accreditation site… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …role. TNCC Instructor status required within one (1) year of hire. TNCC Course Director status required within two (2) years of hire. ATCN validation required ... Preferred Job QualificationsPreferred Licensure or other certifications: TNCC Course Director , ATCN Faculty, ATLS Course Coordinator.Preferred Educational Requirements: Master's… more
- On-Board Companies (Devens, MA)
- …to detail and time management skills. This role will report to the Devens Associate Director , Cell Therapy Site Procurement Lead and can be based at one of the ... lead times, pricing, vendor IDs, UPOM, AUOM, etc.* DCT Verification and Validation : Create, validate, and support Site Procurement Data Files (DCTs) (eg, alternate… more
- DivIHN Integration Inc (Atlanta, GA)
- …business management. THE ROLE Based in San Francisco and reporting to the Director of Product Set-Up and Commercialization this individual will be involved in ... CMD record data setup, data governance rules, creation and validation , as well as change management from active to...data collection, submission of Cherwell setup requests and final validation ending in setup CMD PUSH notification to business,… more
- Fidelity TalentSource LLC (Durham, NC)
- …execution of key implementation activities (example: data conversion load). Participate in validation and/or testing efforts to ensure results meet the client and/or ... product offering requirements. Partnering with the Director Client HealthCare Consulting to define client specific configurable variations to support a client plan… more
