When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary: The Trial Master File (TMF) Specialist will assist in and oversee all aspects of TMF Management. The role oversees the collection, quality assessment, processing and archiving of clinical trials documents from both external and internal sources. The TMF Specialist is responsible for ensuring standard service level agreements in relation to TMF Specialist are maintained and supports the definition, implementation, execution and process improvement of TMF Management activities. Key Accountabilities: - Support and partner with eTMF Business Administrator for account management, create and promote studies in the eTMF and unblinding rules - Act as Subject Matter Expert for eTMF management - Ensure suitable reports and outputs are built to support TMF Quality - Create and support Study Teams in managing the Study TMF Filing plan - Provide day to day document management support - Support TMF review process by working closely with study teams, CROs and Vendors - Ensure Study EDLs and milestones are aligned on and maintained by study teams - Perform and manage TMF Quality reviews and drive for constant inspection readiness of TMFs - Serve as point of contact and support study teams for resolution of TMF-related queries or quality issues - Act as point of contact to support TMF audits and inspections as required - Ensure the CRO’s portion of the TMF is process in a timely and controlled manner - Support the management, tracking and quality of TMF migration from CROs eTMF to eTMF system - Author, contribute to, maintain and implement TMF management controlled documents and associated resources (e.g. training materials, knowledge databases) - Support and/or deliver training across the organization, CRO and Vendors on the policies and procedures relative to and for TMF management - Foster positive relationships with external vendors and internal clinical development areas - Work with CRO partners on the continued development of TMF and record management practices and expectations Qualifications: - Bachelor’s Degree or equivalent - Significant demonstrable TMF lead experience in pharmaceutical/biotechnology industry including records management experience in a GCP-regulated environment - Strong working knowledge of the TMF Reference Model - Strong knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF - Experience of electronic document management system(s) and Veeva eTMF preferred - Working knowledge of Regulatory Agency audits and NDA/MAA Submission triggered inspections preferred. - Strong interpersonal skill sand ability to manage at all levels within a cross-functional organization through influence - Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude - Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc. - Ability to handle a high volume of complex tasks with a given timeline #LI-CF1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

At Kapres Technology, we are looking for an IT Platform Consultant (WMS) to work for a multinational client, a leader in the logistics sector in Europe. Job Purpose: The main purpose of this position is to deliver end-to-end solutions for Warehouse Management Systems (WMS), Order Management Systems (OMS), and system integrations within Contract Logistics operations in Europe. This role requires a dynamic individual that can engage confidently with customers, professionally document requirements, configure multiple systems, manage and perform testing, and provide thorough project or configuration documentation for support teams. This is a systems specialist, with extensive product knowledge on Manhattan WMS that will input to the solution design for new workflows and will describe product extensions to Service Integrators or Manhattan directly. Key Accountabilities: - Requirements Gathering and documentation– Take a lead role in workshops with internal and external key stakeholders to identify requirements and define the agreed scope of the project. - Functional lead - Act as an internal consultant, co-ordinator and liaison between the various parties in the development / configuration of the solution. Suggest solutions for new workflows and requirements - OMS / WMS Configuration implementation – Act as an internal consultant, co-ordinator and liaison between the various parties in the development / configuration of the solution. - Systems Integration – Deliver Paper Mapping documentations describing systems integration between customers and CEVA systems. Implement requirements within integration solutions and test and arrange deployment - Documentation – Provide high-quality documentation detailing systems requirements for the chosen solution and following CEVA Logistics standards. - Testing & Quality Assurance – Prepare test plans and conduct Systems Integration Testing (SIT) ensuring that the end-to-end data exchanges between organisations and systems works as it should, and that the CEVA systems are correctly configured to meet the documented requirements. Support users community when performing Users Acceptance Testing (UAT) - Reporting & Dash boarding – Able to configure BI reporting tools (Cognos) or dashboards (PowerBI) to provide accurate data for business activities. - Other applications – Gather requirements and build functional solutions for other applications (slotting, labor management, invoicing,…) connected to OMS & WMS Requirements: Education & Qualifications: - Bachelor in logistics and/or in Information Technology. Experience: - 3-4 years as Solution Implementers or Business Analyst - Strong logistics/supply chain knowledge - Proven experience implementing Manhattan Active WMS (MAWM) and OMS - Experience in 3PL environments Job modality: Remote within Europe.

Are you interested in being part of an innovative team that supports Westinghouse’s mission to provide clean energy solutions? At Westinghouse, we recognize that our employees are our most valuable asset and we seek to identify, attract and recruit the most qualified talent while recognizing and encouraging the value of diversity in the global workplace. About the role: As an SAP Lead– MFG, Plant Applications, you will be responsible for configuration, implementation, and support of materials management within our multi-system landscape. You will need to have a detailed understanding of all aspects of SAP MM, including MRP, Inventory Management, Supply Chain Management, SD, QM, PP, and PS. You will report to the AP Supervisor-Mfg, Plant Applications. This is a remote position. Key Responsibilities: - Manage all change requests across SAP MM, partnering with Business Process Owners and the SAP COE to prioritize work and assign testers. - Lead workshops to discover, analyze, define and document our requirements; develop blueprints, process flows, main decisions, and functional specifications according to SAP best practices and Westinghouse standards. - Perform and oversee configuration, unit testing, and integration testing for all enhancements and system changes (including ad-hoc query/reports). Record all testing per Westinghouse standards. - Develop initial training materials, collaborate with the SAP Testing & Training team for further editing, and transition final materials for them to deliver training. - Engage directly with users to resolve issues, increase system usage, and support escalations from the SAP support team. Will be responsible for issue resolution during hypercare. - Support cutover planning, go-live preparation, and evaluate impacts of new SAP functionality. Qualifications: - Bachelor's degree in computer science or related field or equivalent experience. - 4+ years of SAP functional experience with SAP material management module (MM). - Hands-on configuration and user experience in SAP material management (MM) functional areas. - Expertise in Material master, Inventory Management, MRP, and BoM. - Experience with purchase requisitions, purchase orders, scheduling agreements, Intra / Inter-company STO, and subcontracting. - Debugging skills to resolve deep seated technical issues. - Experience with SAP development processes (change control, job scheduling, development methodologies, system landscape, application development, and back-up and recovery). We are committed to transparency and equity in all of our people practices. The base salary range for this position, which is dependent upon experience, qualifications and skills, is estimated to be $103,200 to $129,000 per year. #LI-Remote Why Westinghouse? Our benefits package is tailored to meet the diverse needs of our employees, while also promoting wellness and career growth. The following are representative of what we offer: - Comprehensive Medical benefits which could include medical, dental, vision, prescription coverage and Health Savings Account (HSA) with employer contributions options - Wellness Programs designed to support employees in maintaining their health and well-being including Employee Assistance Program providing support for our employees and their household members - 401(k) with Company Match Contributions to support employees' retirement - Paid Vacations and Company Holidays - Opportunities for Flexible Work Arrangements to promote work-life balance - Educational Reimbursement and Comprehensive Career Programs to help employees grow in their careers - Global Recognition and Service Programs to celebrate employee accomplishments and service - Employee Referral Program Westinghouse Electric Company is the global nuclear energy industry's first choice for safe, clean, and efficient energy solutions. We enable our delivery of this vision by living our value system: - Safety and Quality - Integrity and Trust - Customer Focus and Innovation - Speed and Passion to Win - Teamwork and Accountability While our Global Headquarters are located in Cranberry Township, PA, we have over 11,000 employees working at locations in 19 different countries. You can learn more by visiting http://www.westinghousenuclear.com. Westinghouse is an Equal Opportunity Employer including Veterans and Individuals with Disabilities Get connected with Westinghouse on social media: Twitter | Facebook | LinkedIn| YouTube

Company Description Would you like to contribute to exciting digital transformation projects alongside passionate innovators? With Teamwork, the possibilities are endless. We are a private, fast-growing company with a global reach, powered by the Swiss group TeamWork Corporate and 20 years of uninterrupted growth. Joining Teamwork Company means joining our North America-based team of more than 100 experts in an environment that values diversity and international talent. We offer opportunities for continuous learning, a robust benefits package, flexible remote work, and lots of company perks! Who are we? TeamWork is an independent international group, founded in 1999 in Geneva by our current CEO, Philippe Rey-Gorrez. We are your strategic partner in digital transformation, specializing in four core businesses: Management Consulting, SAP Business Solutions, Data Analytics, and Technology Platforms. Recognized by our clients for our expertise and experience, TeamWork supports both major international groups and SMEs. TeamWork Management, the group’s US subsidiary, was created in 2017. With North America offices in Boston, Fort Lauderdale, San Diego, Montreal, and Toronto, our approach is universal: supporting our clients in all aspects of their digital transformation projects Job Description Responsabilities - Lead SAP Basis Team covering implementation, upgrades, hardware sizing and landscape design - Ensure customer needs are met or exceed along with educating them on best practices - Defining systems strategy, developing systems requirements, designing, and prototyping solutions under multiple deadlines - Provide technology leadership and SAP expertise in designing the best technical solution in support of the business requirements - Work with functional teams and the architecture team to determine best practices for the future landscapes Qualifications Education: Bachelor’s degree in Computer Science, IT, Information Systems, Engineering (with IT focus), or closely related field, or foreign equivalent Experience: - Two years of experience in a leadership/management role (team lead, technical manager, or project manager) with responsibility for SAP Basis teams or large SAP projects - At least two years of experience in SAP Basis Administration (system installs, upgrades, performance tuning, patches, migrations). - At least two years of experience in Infrastructure/Systems Administration (servers, databases, operating systems supporting SAP). Technical Skillss Requirements: - SAP Basis administration (implementation, upgrades, patches, transports). - SAP HANA & S/4HANA architecture and administration. - SAP landscape design, hardware sizing, HA/DR setup. - Multi-platform expertise: Linux/Unix, Windows, major DBs (HANA, Oracle, SQL Server, DB2), and cloud (AWS, Azure, GCP) Additional Information Working hours: Monday to Friday: 8:30 am to 5 pm – 40 hours a week Work Locarion: 7801 Mission Center Court, Suite 430, San Diego, CA 92108 - Experience: Junior