Experience with Agile Software development (SAFe preferred) Experience with JIRA and JIRA Align Experience with SDLC Project Management – Program Increment Planning, Sprint Planning, Backlog Grooming, and Daily Sprint Management Capacity and velocity analysis Coordination and planning with development & delivery Ability to manage a multi-function team and prioritize core requirements for MES validation Strong written and communication skills with the ability to effectively communicate to colleagues at all levels Experience with Pharmaceutical Quality Assurance Operations & GxP regulation Possesses expertise in Good Documentation and Good Testing Practices English Required. Italian speaking preferred Show more Show less
Create and/ or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS/ISE) datasets Perform development and validation of analysis dataset, tables, listings and figures for both safety and efficacy parameters Understand and comply with ICH-GCP guidelines, core operating procedures and work instructions. Ensure all programs are compliant with the SOPs and project specific guidelines Provide support in developing ad hoc reports as required Maintain quality and timelines of programming related deliverables Update project related documentation regularly Track and follow up on all issues raised. Experience with R Programming/ Python Show more Show less
Key Responsibilities: Implement and support SAP Logistics Execution (LE) modules including Shipping, Transportation, and Warehouse Integration . Design, configure, and maintain SAP Yard Logistics (YL) solutions to optimize yard operations including gate management, vehicle movements, and resource allocation. Conduct workshops with business stakeholders to gather requirements and define logistics and yard processes. Develop functional specifications for custom developments and enhancements. Collaborate with technical teams for ABAP development and integration with third-party logistics systems. Support end-to-end testing, training, and deployment of SAP LE and YL solutions. Provide post-go-live support and drive continuous improvement initiatives. Work on integration with modules like SAP EWM, MM, SD, TM , and third-party logistics systems. Prepare documentation including process flows, configuration guides, and training materials. Key Requirements: Bachelor’s degree in Computer Science, Engineering, Logistics, or related field. 5–10 years of experience in SAP Logistics Execution (LE) and SAP Yard Logistics (YL) . At least 1–2 full lifecycle implementations of SAP Yard Logistics. Strong hands-on configuration experience in SAP LE (Shipping, Transportation, Delivery Processing). Deep understanding of Yard Logistics functionalities: gate processing, yard resource planning, dock appointments, visual yard layout, etc. Experience integrating SAP YL with SAP EWM, TM , and other logistics systems. Strong analytical and problem-solving skills with the ability to troubleshoot and resolve issues quickly. Excellent communication and interpersonal skills; ability to work with both business and technical teams. SAP Certification in LE or YL is a plus. Show more Show less
Required Skills & Experience: 12+ years of IT experience, with at least 8 years working specifically with ServiceNow. Proven experience as a ServiceNow Architect or Lead Developer across multiple modules. Strong understanding of ServiceNow architecture, data model, and platform capabilities. Experience with integrations using REST/SOAP APIs, MID Servers, and external tools. Deep expertise in at least three of the following: ITSM, HRSD, CSM, ITOM, ITBM Hands-on experience with Flow Designer, Service Portal, Script Includes, Business Rules, UI Policies, ACLs, etc. Strong problem-solving, communication, and leadership skills. Ability to manage multiple projects and priorities in a fast-paced environment. Key Responsibilities: Lead end-to-end design, architecture, and implementation of ServiceNow solutions aligned with enterprise standards and business requirements. Translate business needs into technical solutions within the ServiceNow platform, focusing on scalability and reusability. Collaborate with stakeholders across IT /HR and business to gather requirements, define solutions, and ensure successful delivery. Researches and evaluates alternative solutions and recommends the most efficient and cost-effective solutions. Provide architectural oversight for ServiceNow modules such as ITSM, ITOM, HRSD, CSM and others as needed. Ensure best practices in ServiceNow development, configuration, and integration. Guide development teams by setting standards and ensuring governance and compliance. Create architecture documentation, technical specifications, and solution roadmaps. Evaluate and recommend new ServiceNow features, applications, and capabilities. Lead technical workshops and present architecture solutions to technical and non-technical audiences. Serve as a subject matter expert for ServiceNow platform capabilities and limitations. Lead ServiceNow upgrades planning and execution. Demonstrate high “Speed of Delivery” – being able to rapidly turnaround any deliverables for which they are responsible. Identify and pursue potential ServiceNow Expert Services opportunities at a customer, within and outside of the scope of work. Produces and maintains detailed system documentation including design specs, maintenance, troubleshooting, deployment, disaster recovery, tech notes, and testing, etc. Provide excellent customer service, leadership, communication, problem solving and decision making skills. Show more Show less
Skills needed - Good Python Programming with 6 years of experience; PyCharm; Well versed in AWS tools , will be good if AWS architect certified; GitHub; GitAction; Experience in deploying Data Pipelines. Soft Skills - Good communication skills; Requirement gathering; Aliasing with client Understanding of tools - Jira; Confluence
As an experienced SAP PP and QM Consultant, you will be responsible for configuring, implementing, and supporting SAP PP and QM modules. Your role will involve collaborating with cross-functional teams to understand business requirements and analyzing and optimizing business processes related to production planning and quality management. You will develop functional specifications for custom developments and enhancements and conduct system testing, user training, and post-go-live support. Integration of SAP PP/QM with other SAP modules like MM, SD, and WM will be a key aspect of your responsibilities. In addition, you will be expected to handle master data setup including BOM, routings, inspection plans, work centers, etc. Troubleshooting and resolving SAP issues related to PP/QM, supporting rollouts, upgrades, and patch management, and participating in SAP S/4HANA migration projects if applicable are also part of the role. To excel in this position, you should possess a Bachelor's degree in Engineering, Information Technology, or a related field along with at least 5 years of hands-on experience in SAP PP and QM modules. A strong understanding of discrete/process manufacturing processes, expertise in Master Data Management, MRP, Production Orders, Process Orders, Inspection Lots, Notifications, and Quality Certificates is essential. Knowledge of integration with SAP modules like MM, SD, WM, and PM, experience in working with cross-functional and global teams, and excellent communication and documentation skills are also required. While SAP certification in PP and/or QM is preferred, it is not mandatory. Experience with S/4HANA is also preferred. If you are looking to leverage your SAP PP and QM expertise in a dynamic environment that values innovation and collaboration, this role may be the perfect fit for you.,
Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. * Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. * Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams. * For studies where data management activities are conducted within Takeda, leads and manages clinical trial data collection set-up, data review, and database lock: (a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA. (b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans. (c) Leads data review, including query management, and leads activities required for interim and final database locks. (d) May oversee above activities at the program level. * Participates in preparing function for submission readiness. * Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. * Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. * Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. * Acts as a process expert for operational and oversight models. * May prepare metrics to support the function’s KPIs. * Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
Key Responsibilities: • Configure and customize SAP Customer Data Cloud (CDC), Customer Data Platform (CDP), and SAP Emarsys to meet evolving business and marketing requirements. • Maintain and develop D2C systems across all digital platforms using SAP CDP, CDC, and Emarsys, ensuring personalized customer engagement, compliant data management, and consistent omnichannel experience. • Maintain and develop D2B systems, including the Self-Service Ordering Portal and integrations with SAP Commerce Cloud and Spartacus, utilizing CDC and CDP capabilities. • Develop and implement custom coding solutions in SAP CDC and Emarsys to enhance functionality and improve user experiences. • Design and support integrations between SAP CDx, Emarsys, and other enterprise or third-party platforms via APIs and SAP CPI. • Drive audience segmentation, campaign automation, and personalized communication flows using SAP CDP and Emarsys. • Collaborate with Versuni and TCS teams in the Netherlands and India to align platform development with business objectives. • Perform performance tuning, debugging, and troubleshooting of SAP CDx configurations, data flows, and Emarsys campaigns. • Ensure compliance with security standards, privacy regulations (GDPR, CCPA), and internal data governance policies. • Work on API development, authentication mechanisms (OAuth, SAML), and Single Sign-On (SSO) solutions. • Provide technical support and maintain clear documentation of platform configurations and custom developments. Required Skills & Experience: • Strong hands-on experience with SAP Customer Data Cloud (CDC) and SAP Customer Data Platform (CDP). • Practical experience with SAP Emarsys for marketing automation, segmentation, personalization, and omnichannel orchestration. • Proven experience developing and maintaining systems across D2C and D2B channels using SAP CDx and Emarsys tools. • Proficiency in JavaScript, SAP BTP, Node.js, or related technologies. • Strong knowledge of RESTful APIs, OAuth, SAML, and other authentication/authorization mechanisms. • Experience in debugging and troubleshooting system integrations and performance bottlenecks. • Understanding of customer data architecture, privacy, consent management, and preference center configurations. • Familiarity with Agile/Scrum methodologies. • Excellent verbal and written communication skills; ability to work in cross-functional, geographically distributed teams. Preferred Qualifications: • SAP CDC and/or SAP Emarsys certifications. • Experience with SAP Commerce Cloud or other SAP CX solutions. • Experience with cloud platforms such as SAP BTP, AWS, or Azure. • Experience working in a global, distributed team setup. • Exposure to use cases involving product recommendations, behavioral triggers, and real-time personalization via Emarsys.
Preferred 5 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function. Proven track record of strong project management skills and experience managing data management activities for large drug development programs. Experience with all phases of development in one or more therapeutic areas preferred. Ability to handle multiple development programs simultaneously. NDA/CTD Experience preferred. Strong knowledge of data management best practices & technologies as applied to clinical trials. Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
Full life cycle implementation experience in SAP GTS, including Design, Analyse, Development, Customization, Assembly and extensive integration testing, Master data management, End user training and cutover activities. • Experience in SAP GTS Implementation, Support, and rollout projects. • Worked on S/4 Hana with SAP GTS 11.0 implementation. • Worked in Chemicals, Pharma and Healthcare Industries. • Customs management: Configuration experience in AES/ATLAS for setting up communication process for generating EU/US Customs declarations import/exports, configuring PPF (post-processing Framework) for generation of Forms, defining default data, electronic filing with customs authorities via See burger middleware. • Master Data Set up for GTS: Product Classification (ECCN, HTS), Business Partners, Integration of Third-party data for Denied Party Lists, Customs Offices, Customs duty rates. • Experience in Integrating with See burger BIS6 for automatic filing. • Experience in Customs process imports and export declarations integrated with customs broker interfaces and forwarder broker interfaces as per country legal regulations. • Experience in setting up Customs bonded warehouse processes in EU and APAC. • Compliance Management: Settings for Sanctioned party list (SPL) screening, Embargo, Legal control thru license management (Defining and assigning numbering schemes to Legal regulations, Activation of defined Legal regulations, maintaining the control settings for the defined Legal regulations, Defining, and assigning License types, Maintaining/Uploading ECCN’s, uploading Product Classification files, maintaining License determination strategy)
Create and/ or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS/ISE) datasets Perform development and validation of analysis dataset, tables, listings and figures for both safety and efficacy parameters Understand and comply with ICH-GCP guidelines, core operating procedures and work instructions. Ensure all programs are compliant with the SOPs and project specific guidelines Provide support in developing ad hoc reports as required Maintain quality and timelines of programming related deliverables Update project related documentation regularly Track and follow up on all issues raised. Experience with R Programming/ Python
Key Responsibilities: Program listings and mappings Create visualizations Hands on exposure in reviewing Clinical Data in JReview Automation of tasks Configure data extraction and transformations in an individual contributor role across multiple data sources at the study level as defined by the Data Transfer Agreement and other specifications provided by Data Engineer Partner closely with internal/external stakeholders and data engineers in a collaborative manner Ensure accurate delivery of data format and data frequency with quality deliverables per specification. Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business. Additional Activities: Assists with quality review of above activities performed by a vendor, as needed. Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned within timelines.