Job Summary: 

• Assist in the execution, coordination, and review of medical/scientific documents for radiological imaging studies in clinical trials.
• Assist in business development and proposal documentation activities
• Research new imaging and radiomic criteria and techniques for assessing clinical trial outcomes.
• Provide writing/research support for publishing activities in medical/scientific journals.
• Collaborate and communicate effectively with internal and external teams.
• Prepare, handle, distribute, file, and archive clinical documentation and reports.
• Record meeting minutes and create lists of deliverables.
• Ensure timely updates to the project tracker.
• Effectively communicate project-related information.
• Maintain confidentiality and adhere to HIPAA and GDPR.
• Perform departmental administrative tasks

Skills on Resume:

• Medical/Scientific Writing (Hard Skills)
• Business Development Support (Soft Skills)
• Radiological Imaging Research (Hard Skills)
• Publishing Support (Hard Skills)
• Team Collaboration (Soft Skills)
• Document Management (Hard Skills)
• Project Tracking and Reporting (Hard Skills)
• Confidentiality and Compliance (Hard Skills) 

Job Summary: 

• Responsible for overall coordination and control of documentation within the company
• Maintains and controls Document Control logs, Validation logs, Engineering Drawing/Specification logs, etc.
• Assist in coordinating Quality Management System training for the organization
• Assists in external and internal audits including regulatory audits
• Performs self-audits for systems within Document control
• Maintains all quality records, work instructions, templates, forms, and procedures related to Quality Management System
• Responsible for coordinating Document change orders, review, and approval of Document change orders for Document Control.
• Responsible for managing continuous improvement initiatives within the Document Control
• Ensure compliance with all document control regulations and procedures
• Assist in developing/updating Document control procedures/system

Skills on Resume:

• Document Control Management (Hard Skills)
• Quality Management System (Hard Skills)
• Audit Support (Soft Skills)
• Self-Auditing (Hard Skills)
• Record Keeping (Hard Skills)
• Change Order Coordination (Hard Skills)
• Continuous Improvement (Soft Skills)
• Regulatory Compliance (Hard Skills) 

Job Summary: 

• Support global and regional document owners with protocol governance submissions to governance committees
• Manage calendaring of weekly meeting reviews, sending Outlook invites, and tracking of required attendees
• Perform Quality Control (QC), proofreading, and editing of study documents before uploading to the document management system (e.g. EPIC)
• Upload study summary documents into the document management system
• Act as liaison between authors and approving governance body to speed the submission process.
• Act as department representative to communicate and educate on governance processes, answer general questions, troubleshoot problems, and assist in resolution.
• Manage and update SharePoint tracker and provide regular metrics reporting
• Track document milestones and completion
• Prepare training materials for study document submissions to governance
• Provide training and guidance to new team members
• Run and prepare reports from tracking systems to monitor publications and compliance
• Assist with special projects

Skills on Resume:

• Document Governance (Hard Skills)
• Meeting Coordination (Soft Skills)
• Quality Control and Proofreading (Hard Skills)
• Document Management System (Hard Skills)
• Liaison and Communication (Soft Skills)
• SharePoint Management (Hard Skills)
• Reporting and Metrics (Hard Skills)
• Training and Onboarding (Soft Skills) 

Job Summary: 

• Take responsibility for issuing document numbers.
• Route the controlled documents for review and sign-off.
• Timely distribution of the latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution.
• Responsible for the accuracy of all controlled documents.
• Maintain a computer database of all filed documentation that ensures fast retrieval of documents via the company intranet website.
• Maintain historical files for Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Design Reviews, Validations, SOPs, and other quality system documents.
• Manage archival activities for controlled documents and validation files to meet requirements of QSR 820, ISO 13485, CLIA, CAP, and State Standards.
• Maintain company training records.
• Train others on the document control system
• Per procedures, grant access to defined systems (i.e. LIMS, Document Control system).

Skills on Resume:

• Document Control (Hard Skills)
• Document Distribution (Soft Skills)
• Accuracy Verification (Hard Skills)
• Database Management (Hard Skills)
• Historical File Maintenance (Hard Skills)
• Archival Management (Hard Skills)
• Training and Development (Soft Skills)
• System Access Management (Hard Skills) 

Job Summary: 

• Responsible for the functioning and utilization of the document control system for the project.
• Provide team members with training and guidance.
• Assist in creating/implementing and auditing a reporting system to track all NCRs, CARs, and other documentation deemed critical by the project from start to finish.
• Oversee the receipt, capture, control, and access of all project documents.
• Assist in the turnover of deliverable documentation as defined in project procedures.
• Set up a hard copy filing system and maintaining wet signature hard copy filing
• Contractually provide hard copies and soft copies of documentation to the Client
• Provide required document retention documentation.
• Communicate with internal and external staff routinely for status updates and troubleshooting to maintain schedule and management software accuracy.
• Validate data provided by consultants/contractors.
• Identify potential risk trends.
• Work with the PMIS system and functions, and how the system is set up to perform minor programming tasks within the application.

Skills on Resume:

• Document Control Management (Hard Skills)
• Training (Soft Skills)
• Reporting System (Hard Skills)
• Document Control (Hard Skills)
• Document Turnover (Hard Skills)
• Filing System (Hard Skills)
• Communication (Soft Skills)
• Risk and Data Validation (Hard Skills) 

Job Summary: 

• Manages to file and update information quality system documentation
• Manages the database controlling documentation.
• Files and maintains the standards library
• Files and maintains the calibration database
• Posts changes to computerized or manual control records release documents and notify affected departments.
• Manages complex document control projects like labeling revision and localization
• Maintains the training database
• Supports general administrative functions
• Provide support for regulatory affairs
• Assist with schedule creation, updating, development, and reporting of Capital Improvement Projects (CIP).

Skills on Resume:

• Document Filing and Management (Hard Skills)
• Database Management (Hard Skills)
• Standards Library Maintenance (Hard Skills)
• Calibration Database Maintenance (Hard Skills)
• Document Control (Hard Skills)
• Training Database Maintenance (Hard Skills)
• Administrative Support (Soft Skills)
• Regulatory Affairs Support (Soft Skills) 

Job Summary: 

• Manage hardcopy document collections (Project Development Related)
• Use computer applications to build tracking systems and communicate needs/status
• Generate and/or review/approve project-related validation, change control, or other documentation
• Participate in meetings to understand requirements and drive timely completion of team deliverables
• Provide support to colleague PM assigned to project sub-team
• Use Excel spreadsheets to document and organize data when requested
• Create reports, track and communicate the status of team deliverables to Key Stakeholders
• System Interface (SAP, QTS, PDOCs, etc...)
• Immediately escalate issues with potential project timeline impact
• Manage the completion of weekly work targets and report the weekly status of progress, issues, and risks to project management
• Generate and/or review/approve various documentation and project deliverables
• Effectively leads/facilitates/participates/completes cross-functional team deliverables

Skills on Resume:

• Document Management (Hard Skills)
• Tracking System Development (Hard Skills)
• Documentation Review and Approval (Hard Skills)
• Team Collaboration (Soft Skills)
• Data Organization (Hard Skills)
• Reporting and Communication (Soft Skills)
• System Interface Management (Hard Skills)
• Issue Escalation (Soft Skills) 

Job Summary: 

• Serves as a champion of Worldwide’s QMS by participating and encouraging a strong quality culture
• Performs document control activities throughout the GxP QMD lifecycle, including supporting the development, deployment, revision, retirement, and archiving of QMDs
• Supports tracking, and reporting of metrics for document control and internal compliance functions
• Contributes to preparation for the QMD Governance Committee (QMD-GC) meeting
• Assists in administrative duties regarding QMD-GC quorum management, minutes, and archiving
• Assists with the maintenance of the QMD Master Index, SOP Master Index, eQMS data entry, QMD deviation routing, tracking and archiving, and with other QMD management trackers and tools
• Supports the process for external dissemination of Worldwide’s QMDs
• Collaborates with internal stakeholders to ensure compliance with the QMS and QMD lifecycle procedures
• Executes individual goals for and supports team objectives of the QA document control organization
• Participate in other departmental or cross-functional initiatives

Skills on Resume:

• Quality Management System (QMS) Support (Hard Skills)
• Document Control (Hard Skills)
• Metrics Tracking and Reporting (Hard Skills)
• Meeting Preparation and Support (Soft Skills)
• Administrative Support (Soft Skills)
• QMD Master Index Maintenance (Hard Skills)
• Compliance Collaboration (Soft Skills)
• Cross-Functional Initiative Participation (Soft Skills) 

Job Summary: 

• Facilitate through work teams the development and reviewing of Quality documentation (i.e. Business Manual, Guidelines, Procedures, and Work Instructions) in alignment with Endeavour Foundation business requirements, linked with organizational strategic directions and industry standards.
• Carry out audits, follow business plans, and ensure business objectives are met.
• Develop and maintain document control standards and procedures and ensure their consistent adoption in all areas of the business.
• Oversee the development and implementation of quality forms and process mapping concerning strategic business plans.
• Maintain quality documentation regarding both hardcopy and computer records and take full responsibility for the electronic systems currently used.
• Manage all flows of documents either in electronic form or on paper support.
• Ensure ongoing Compliance with relevant regulatory and legislative requirements as well as Endeavour Foundation's Internal Policies
• Perform SharePoint administrative tasks.
• Assist with the maintenance and upgrading of project management systems, including workflows, dashboards, and external reports.
• Perform all work safely and responsibly, following the Health and Safety Plan.

Skills on Resume:

• Quality Documentation Development (Hard Skills)
• Auditing and Compliance (Hard Skills)
• Document Control Standards (Hard Skills)
• Process Mapping (Hard Skills)
• Documentation Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• SharePoint Administration (Hard Skills)
• Health and Safety Adherence (Soft Skills) 

Job Summary: 

• Take responsibility for troubleshooting by liaising with IT
• Maintain library distributions, as well as a participant matrix.
• Provide team members with guidance when required.
• Use and update a project distribution Matrix for use in documentation communication via transmittal, memo, or email in DMS systems.
• Responsible for achieving and maintaining a high level of accuracy in capturing meta-data in the DMS system following procedures and requirements for metadata for reporting/auditing.
• Manage and coordinate the metadata and the process of storage for documents in the DMS system by all internal and external parties.
• Assist in providing support to all project participants regarding the project document control practices
• Identify and escalate processing issues or other system issues to the project Document Control Manager promptly.
• Participate in other project document control initiatives or data management tasks under the direction of the project Document Control Manager or bids Document Control Manager.
• Allocate project document/drawing numbers per the guidance of the Document Control Manager and procedures.
• Use Aconex to assist in the Creation/Communication/implementation and maintenance of a reporting system to track by originator all RFI’s from the date of receipt by Aecon, through to the return of the response to the originating party Report on all overdue responses.
• Oversee the receipt, capture, control, and access of all Bid documents.

Skills on Resume:

• Troubleshooting (Soft Skills)
• Document Management (Hard Skills)
• Metadata Management (Hard Skills)
• DMS System Usage (Hard Skills)
• Team Guidance (Soft Skills)
• Project Documentation Communication (Hard Skills)
• Issue Escalation (Soft Skills)
• Reporting and Tracking (Hard Skills)