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Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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2+ Experience using NICE Actimize Case Management solution development (ActOne / RCM) Position will involve design, coding, and configuration management of Actimize Case Manager applications.
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University degree in Marketing, Business/Management, Communication with industry focus on Advertisement (strategic planning), Consumer Insights. As an Innovation Manager within the North American Innovation team reporting to the Innovation Director, you will be on-site as a part of the East Hanover Creative Center for Consumer Products (Personal Care, Home Care, and Laundry Care), and you will join a dynamic diverse group of professionals.
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PwC Professional skills and responsibilities for this management level include but are not limited to:Use feedback and reflection to develop self awareness, personal strengths and address development areas.
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The Wax Process Owner will foster continuous improvement utilizing Process management designed experiments, IPM and SPC, Cpk. Ability to effectively present information and respond to questions from the customer and/or management.
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ExamWorks is a leading provider of innovative healthcare services including independent medical examinations, peer reviews, bill reviews, Medicare compliance, case management, record retrieval, document management and related services.
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NV5 is a provider of engineering and consulting services to public and private sector clients, delivering solutions through six business verticals: Testing, Inspection & Consulting; Infrastructure; Utility Services; Environmental Health Sciences; Buildings & Program Management; and Geospatial Technology.
$35 an hourFull-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Asembia focuses on the specialty pharmacy segment and offers comprehensive hub services, pharmacy network management, group purchasing (GPO) services, innovative technology platforms and more. As a leading industry voice and advocate, Asembia is committed to bringing strategic channel management solutions, leading-edge products and high-touch services to the specialty pharmacy industry that help our customers optimize patient care and outcomes.
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SnowflakeSource Code Management tools and best practices (similar to: Git, Git Actions, branch management)Working knowledge of:CI/CD Pipelines (similar to: Jenkins, UCD)Process Orchestration Tools (similar to: AutoSys, Airflow, Step Functions )Infrastructure as Code (similar to: Terraform, CloudFormation)DatabricksPython/PysparkWhat is a Must Have.
$121 - $199Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with cross-functional teams, including Quality Assurance, Quality Control, Engineering, and Production Management. Other duties as required and assigned by management. Lead and execute complex aseptic processing tasks, including setup, sterilization, formulation, filling, lyophilization, per work instructions, standard operating procedures and batch record process steps.
$93,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Strong attention to detail and ability to present to key stakeholders including senior management and regulators Desirable skills/Preferred Qualifications: Experience in other areas of regulatory reporting including 15c3-3 Customer Reserve, CFTC segregation requirements, and the Possession or Control Requirements of SEC Rule 15c3-3 Detail oriented and strong analytical aptitude - ability to work efficiently with advanced spreadsheets and solve problems with minimal guidance.
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Building and managing CI/CD (Continuous Integration/Continuous Delivery) workflows and complex system integration using DevOps scripts and frameworks/tools Gitlab, Jenkins, BitBucket, Nexus, CVS and AppviewX. Hands on experience in scripting languages (shell, python, groovy), Terraform modules/templates, CloudFormation(AWS) or other Public Cloud platforms, operating systems (Linux and windows), Configuration Management tools (Chef or Puppet), network fundamentals to build automation framework.
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Experience in Risk Management Framework (RMF) accreditation and authorization (A&A) processes to include RMF steps 1-4 (categorization, controls selection, control implementation, security assessment) and standard body of evidence (BoE) package development.
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FM helps clients maintain continuity in their business operations by drawing upon state-of-the-art loss-prevention engineering and research; risk management skills and support services; tailored risk transfer capabilities; and superior financial strength.
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Innova Solutions is immediately hiring a Trial Supplies ManagerJob Title: Trial Supplies ManagerPosition type: Full-time ContractDuration: 06 MonthsLocation: Remote, USAPay range: $74 -$ 78 Per HourAs a Trial Supplies Manager, you will:This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.
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