44 Veeva Vault Jobs

Role- Veeva Automation Tester Job Description Experience in implementation, technical design, migration and integration architecture for Veeva Vault MedComms and PromoMats Configuration Experience in building and executing Veeva Vault APIs Experience in building solutions and interfaces with Veeva Vault

Role- Job Description Responsibility of / Expectations from the Role Ability to configure in Veeva Vault Medcomms and Promomats Vault Ability to provide the technical solution on time after understanding the complexity of the problem. Should be able to identify document flows in/between business processes, and be able to provide new solutions for the optimization of document flows. Experience in gathering customer requirements and writing functional and technical design documentation Should be able to create, configure, and document solutions under minimal supervision.

In this vital role, you'll be responsible for developing and maintaining the overall data architecture and integration of Amgen's Veeva Vault Platform. This includes defining the data integrations vision, creating roadmaps, and ensuring that IT strategies align with business goals. You'll work closely with stakeholders to understand requirements, develop data integration blueprints, and ensure that solutions are scalable, secure, and aligned with enterprise standards. You'll be involved in defining the Veeva Vault Platform data integration, guiding technology decisions, and ensuring that all implementations adhere to established architectural principles, Veeva's, and the industry's best practices. You'll also collaborate with the broader stakeholder community regarding their data needs, including data quality, data access controls, and compliance with privacy and security regulations. Roles & Responsibilities Work with Enterprise MDM and Reference Data to implement standards and data reusability. Contribute to and support consistency with data governance principles. Maintain documentation on data definitions, data flows, common data models, data harmonization, etc. Partner with business teams to identify compliance requirements with data privacy, security, and regulatory policies for the assigned domains. Build strong relationships with key business leads and partners to ensure their needs are met. Be a key team member assisting in the design and development of data pipelines for the Veeva Vault platform. Create data pipelines and ensure data quality by implementing ETL processes to migrate and deploy data across systems. Contribute to the design, development, and implementation of data pipelines, ETL/ELT processes, and data integration solutions. Take ownership of data pipeline projects from inception to deployment; manage scope, timelines, and risks. Identify and resolve complex data-related challenges. Explore new tools and technologies that will help improve ETL platform performance. Participate in sprint planning meetings and provide estimations on technical implementation. Work with data engineers on data quality assessment, data cleansing, and data analytics. Share and discuss findings with team members practicing the SAFe Agile delivery model. Automate and optimize data pipelines and frameworks for easier and cost-effective development processes. Advise and support project teams (project managers, architects, business analysts, and developers) on cloud platforms (AWS, Databricks preferred), tools, technology, and methodology related to the design, build scalable, efficient, and maintain Data Lake and other Big Data solutions. Experience developing in an Agile development environment, and comfortable with Agile terminology and ceremonies. Stay up to date with the latest data technologies and trends. Basic Qualifications Education and Experience:Master's degree with 4 - 6 years of experience in Computer Science, IT, or a related field; OR Bachelor's degree with 6 - 8 years of experience in Computer Science, IT, or a related field; OR Diploma with 10 - 12 years of experience in Computer Science, IT, or a related field. Functional Skills Must-Have Skills Solid understanding of architecting Veeva Vault Platforms/Products. Strong knowledge of Data Lake technologies like Databricks, etc. Experience in MuleSoft, Python scripting, and REST API script development. Extensive knowledge of enterprise architecture frameworks, technologies, and methodologies. Experience with system integration and IT infrastructure. Experience with data, change, and technology governance processes on the platform level. Experience working in Agile methodology, including Product Teams and Product Development models. Proficiency in designing scalable, secure, and cost-effective solutions. Have stakeholder and team management skills. Ability to lead and guide multiple teams to meet business needs and goals. Good-to-Have Skills Good knowledge of the Global Pharmaceutical Industry. Understanding of GxP processes. Strong solution design and problem-solving skills. Solid understanding of technology, function, or platform. Experience in developing differentiated and deliverable solutions. Ability to analyze client requirements and translate them into solutions. Willingness to work late hours. Professional Certifications Veeva Vault Platform Administrator (mandatory) SAFe DevOps Practitioner (preferred) SAFe for teams (preferred) Soft Skills Excellent critical-thinking and problem-solving skills. Strong communication and collaboration skills. Demonstrated awareness of how to function in a team setting. Demonstrated awareness of presentation skills.

Manager Information Systems What you will do In this vital role you will responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Lead the design, configure and deployment of the validation systems (such as Veeva Validation Management, ALM, and KNEAT) ensuring scalability, maintainability, and performance optimization. Implement standard methodologies, conduct code review and provide technical guidance, mentorship to junior developers. Take ownership of complex software projects from conception to deployment. Manage software delivery scope, risk, and timeline Collaborate closely with business collaborators to discuss requirements, ensuring alignment between technical capabilities and business objectives, while effectively communicating any technical limitations or constraints. Contribute to both front-end and back-end development using cloud technology. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Ensure all documents are compliant with 21 CFR Part 11, Annex 11, and other relevant regulations. Identify and resolve technical challenges effectively. Stay updated with the latest trends and advancements. Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a partner concern point and facilitating communication when service commitments are not met. Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree and 4 to 6 years of related field experience OR Bachelors degree and 6 to 8 years of related field experience OR Diploma and 10 to 12 years of related field experience Solid technical background, including understanding software development processes, databases, and cloud-based systems. Experience configuring the SaaS systems such as Veeva or ALM. Experience with Document management system, Service now suite, ALM, JIRA, Veeva Platform, GenAI. Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements. Preferred Qualifications: Understanding of Veeva Quality Vault/ALM/KNEAT. Curiosity of modern technology domain and learning agility Experience with the following technologies Veeva Vault, MuleSoft, AWS (Amazon Web Services) Services (DynamoDB, EC2, S3, etc.), Application Programming Interface (API) integration and Structured Query Language (SQL) will be a big plus. Excellent communication skills, with the ability to convey complex technical concepts. As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

Sr. Data Engineer Veeva Integration Lead What you will do In this vital role you will be responsible for developing and maintaining the overall data architecture and integration of Amgens Veeva Vault Platform. This role involves defining the data integrations vision, creating roadmaps, and ensuring that IT strategies align with business goals. The role will be working closely with collaborators to understand requirements, develop data integration blueprints, and ensure that solutions are scalable, secure, and aligned with enterprise standards. The role will be involved in defining the Veeva Vault Platform data integration, guiding technology decisions, and ensuring that all implementations adhere to established architectural principles, Veevas and the Industrys standard methodologies. Collaborate with broader collaborator community with their data needs, including data quality, data access controls, compliance with privacy and security regulations. Works with Enterprise MDM and Reference Data to implement standards and data reusability. Contribute and support consistency to data governance principles. Maintain documentation on data definitions, data flows, common data models, data harmonization etc. Partner with business teams to identify compliance requirements with data privacy, security, and regulatory policies for the assigned domains Build strong relationships with key business leads and partners to ensure their needs are met. Be a key team member that assists in design and development of the data pipeline for Veeva Vault platform Create data pipelines and ensure data quality by implementing ETL processes to migrate and deploy data across systems Contribute to the design, development, and implementation of data pipelines, ETL/ELT processes, and data integration solutions Take ownership of data pipeline projects from inception to deployment, manage scope, timelines, and risks Identify and resolve complex data-related challenges Explore new tools and technologies that will help to improve ETL platform performance Participate in sprint planning meetings and provide estimations on technical implementation Work with data engineers on data quality assessment, data cleansing and data analytics Share and discuss findings with team members practicing SAFe Agile delivery model Automate and Optimize data pipeline and framework for easier and cost-effective development process. Advice and support project teams (project managers, architects, business analysts, and developers) on cloud platforms (AWS, Databricks preferred), tools, technology, and methodology related to the design, build scalable, efficient and maintain Data Lake and other Big Data solutions Experience developing in an Agile development environment, and comfortable with Agile terminology and ceremonies. Stay up to date with the latest data technologies and trends. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelors degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field Must-Have Skills: Solid understanding of architecting Veeva Vault Platforms/Products Strong knowledge of Data Lake technologies like Databricks, and etc. Experience in Mulesoft, Python script and REST API script development Extensive knowledge of enterprise architecture frameworks, technologies and methodologies Experience with system integration and IT infrastructure Experience with data, change, and technology governance processes on the platform level Experience working in agile methodology, including Product Teams and Product Development models Proficiency in designing scalable, secure, and cost-effective solutions. Have collaborator and team management skills Have the ability to lead and guide multiple teams to meet business needs and goals Good-to-Have Skills: Good Knowledge of Global Pharmaceutical Industry Understanding of GxP process Strong solution design and problem-solving skills Solid understanding of technology, function, or platform Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Working late hours Professional Certifications: Veeva Vault Platform Administrator (mandatory) SAFe DevOps Practitioner (preferred) SAFe for teams (preferred) Soft Skills: Excellent critical-thinking and problem-solving skills Strong communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation skills

Associate IS Bus Sys Analyst What you will do In this vital role you will we are seeking a highly skilled Associate IS Bus Sys Analyst to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Maintain existing code and configurationSupport and maintain SaaS applications Development & DeploymentDevelop, test, and deploy code based on designs created with the guidance of senior team members. Implement solutions following standard methodologies for code structure and efficiency. DocumentationGenerate clear and concise code documentation for new and existing features to ensure smooth handovers and easy future reference. Collaborative DesignWork closely with team members and collaborators to understand project requirements and translate them into functional technical designs. Code Reviews & Quality AssuranceParticipate in peer code reviews, providing feedback on adherence to standard methodologies, and ensuring high code quality and maintainability. Testing & DebuggingAssist in writing unit and integration tests to validate new features and functionalities. Support fix and debugging efforts for existing systems to resolve bugs and performance issues. Perform application support and administration tasks such as periodic review, manage incident response and resolution, and security reviews. Continuous LearningStay up-to-date with the newest technologies and standard methodologies, with a focus on expanding knowledge in cloud services, automation, and secure software development. What we expect of you Must-Have Skills: Solid technical background, including understanding software development processes, databases, and cloud-based systems. Experience configuring SaaS applications (such as Veeva). Experience working with databases (SQL/NoSQL). Strong foundational knowledge of testing methodologies. Good-to-Have Skills: Understanding of Veeva Quality Vault/ALM/KNEAT. Curiosity of modern technology domain and learning agility Experience with the following technologies Veeva Vault, MuleSoft, AWS (Amazon Web Services) Services (DynamoDB, EC2, S3, etc.), Application Programming Interface (API) integration and Structured Query Language (SQL) will be a big plus. Superb communication skills, with the ability to convey complex technical concepts. Qualification: Bachelors Degree and 0to 3 years of experience in software development processes, databases, and cloud-based systems Diploma and 4 to 7 years of experience in software development processes, databases, and cloud-based systems

Veeva Vault Quality Management System (QMS) Specialist Job Overview We are seeking a skilled Veeva Vault Quality Management System (QMS) Specialist, Aboobacker, to manage and optimize our Veeva Vault QMS platform. This role ensures seamless administration, configuration, and compliance of quality processes, collaborating with cross-functional teams to enhance operational efficiency and regulatory adherence in a life sciences environment. Key Responsibilities Serve as the primary administrator for Veeva Vault QMS, managing configuration, workflows, and triggers for quality processes such as audits, deviations, and supplier qualifications. Collaborate with business process owners to design and implement QMS workflows, ensuring alignment with regulatory requirements (e.g., FDA, EMA, GxP, and ICH guidelines). Support integration of Veeva Vault QMS with other systems (e.g., QualityDocs, RIM) using Vault Connections to streamline change control and data synchronization. Develop and maintain dashboards, reports, and metrics to monitor quality processes and ensure inspection readiness. Conduct system testing, validation, and change control assessments for new releases and enhancements, ensuring compliance with GAMP 5 standards. Provide end-user training and support, creating training materials and resolving technical issues to minimize downtime. Implement protocols for data integrity, backup, disaster recovery, and system security to ensure HIPAA and regulatory compliance. Proactively identify and resolve system issues, driving continuous improvement in quality management processes. Qualifications Bachelors degree in a related field (e.g., Life Sciences, Computer Science, or Engineering) with 5+ years of experience in quality management or system administration in a pharmaceutical or biotech environment. Proven expertise in Veeva Vault QMS administration, configuration, and workflow design. Strong knowledge of GxP, FDA, EMA regulations, ICH guidelines, and quality assurance/control operations. Experience with system validation (GAMP 5 Category 4) and regulatory audits. Excellent communication, problem-solving, and collaboration skills, with the ability to work in a team-based environment. Familiarity with Veeva Vault integrations (e.g., QualityDocs, RIM) and APIs is a plus. Preferred Skills Experience with Veeva Vault QualityDocs or Training modules. Knowledge of SQL, relational databases, or data analytics for reporting. Certification in Veeva Vault administration or quality management systems. *************************************************************************************************** Veeva Vault Learning Management System (LMS) Specialist Job Overview We are looking for a dedicated Veeva Vault Learning Management System (LMS) Specialist, Aboobacker, to oversee the administration and optimization of our Veeva Vault Training platform. This role manages training content, curricula, and compliance, ensuring role-based qualification and GxP readiness for life sciences professionals. Key Responsibilities Administer Veeva Vault Training, configuring training workflows, curricula, and assignments for documents, videos, eLearning, and on-the-job training. Collaborate with functional area heads to develop and approve training content, ensuring alignment with GxP job functions and regulatory requirements. Create and manage role-based training matrices, tracking qualification and compliance status via reports and dashboards. Integrate Veeva Vault Training with QualityDocs to automate re-training based on document changes and ensure seamless content access. Provide end-user training, develop training materials, and support users in navigating the LMS, resolving issues promptly. Conduct data integrity checks and prepare for regulatory audits, ensuring Part-11 compliance and inspection readiness. Support the implementation of new training modules, assess system updates for training impact, and manage change control processes. Maintain system security, user accounts, and data backup protocols to safeguard training data and ensure HIPAA compliance. Qualifications Bachelors degree in a related field (e.g., Life Sciences, Education Technology, or Computer Science) with 5+ years of experience in training management or LMS administration in a regulated industry. Expertise in Veeva Vault Training administration, configuration, and content management. Strong understanding of GxP training requirements, FDA Part-11, and regulatory compliance in life sciences. Experience with training matrix development and regulatory audit preparation. Excellent organizational, communication, and problem-solving skills. Familiarity with Veeva Vault integrations (e.g., QualityDocs) and eLearning standards (e.g., SCORM) is a plus. Preferred Skills Experience with Veeva Vault QMS or QualityDocs modules. Proficiency in data analytics for training compliance reporting. Certification in Veeva Vault administration or learning management systems. *************************************************************************************************** Veeva Vault Document Management System (DMS) Specialist Job Overview We are seeking a proficient Veeva Vault Document Management System (DMS) Specialist, Aboobacker, to manage and optimize our Veeva Vault QualityDocs platform. This role focuses on the administration, configuration, and compliance of document management processes, ensuring efficient document lifecycle management and regulatory adherence in a life sciences environment. Key Responsibilities Administer Veeva Vault QualityDocs, managing document types, lifecycles, workflows, and permissions to support controlled document processes. Collaborate with stakeholders to design and implement document management workflows, ensuring compliance with regulatory standards (e.g., FDA, EMA, GxP). Support integration of Veeva Vault QualityDocs with QMS and Training modules to enable seamless document access and automated processes. Develop and maintain document metadata, reports, and dashboards to track document status and ensure audit readiness. Perform system testing, validation, and change control for new features and releases, adhering to GAMP 5 standards. Provide end-user training and support, creating user guides and troubleshooting document management issues to minimize disruptions. Implement data backup, disaster recovery, and security protocols to protect sensitive documents and ensure HIPAA compliance. Drive continuous improvement by optimizing document workflows and resolving system performance issues. Qualifications Bachelor’s degree in a related field (e.g., Life Sciences, Information Systems, or Computer Science) with 5+ years of experience in document management or system administration in a regulated industry. Proven expertise in Veeva Vault QualityDocs administration, configuration, and document lifecycle management. Strong knowledge of GxP, FDA Part-11, and document control requirements in life sciences. Experience with system validation and regulatory audit preparation. Excellent communication, analytical, and collaboration skills, with a focus on detail-oriented process optimization. Familiarity with Veeva Vault integrations (e.g., QMS, Training) and metadata management is a plus. Preferred Skills Experience with Veeva Vault QMS or Training modules. Knowledge of document metadata standards and reporting tools. Certification in Veeva Vault administration or document management systems. Benefits (Applicable to All Roles) Competitive salary and comprehensive benefits package. Opportunities for professional growth, including Veeva certification programs. Flexible, remote-friendly work environment. Collaborative culture focused on innovation, compliance, and excellence in life sciences. Application Process To apply for any of these positions, please submit your resume and cover letter to [insert application email/link], specifying the role (QMS, LMS, or DMS Specialist) in the subject line. We look forward to welcoming Aboobacker or another qualified candidate to our team to drive excellence in Veeva Vault platform management.

What you will do In this vital role you will coach who facilitates team with Scrum events, processes, and supports teams in delivering value for Veeva Vault Team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, handling risks and dependencies, and driving relentless improvement. The Scrum master help adapt SAFe to the organizations needs, standardizing and documenting practices. The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. Roles & Responsibilities: Lead and handle product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team. Assemble the voice of the customer to define business processes and product needs Collaborate with business collaborators, Architects and Engineering teams to prioritize release scopes and refine the Product backlog Lead and facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and handle risks associated with the systems, requirement validation, and user acceptance Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT or related field OR Bachelors degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, Business, Engineering, IT or related field. Must-Have Skills: 6-8 years of experience working in global pharmaceutical Industry Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager Vault etc. Good-to-Have Skills: Proficiency in automation tools and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodologies. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile etc.). Professional Certifications: SAFe for Teams (preferred) Veeva Vault Platform Administrator (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

About organization ResMed is a global leader in connected devices and digital health. We help millions of people sleep, breathe and live better lives. Are you ready to help fuel our growth? As ResMed continues to evolve with the future of healthcare, our customer-centric organization focuses on cloud-connected devices and digital health technologies that are designed to help treat and manage sleep apnea, COPD, and other chronic respiratory diseases that, together, affect over one billion people worldwide. If you share a passion for transforming care, keeping people healthy and out of the hospital, and lowering healthcare costs, ResMed invites you to apply to an applicable role. Lets talk about the team Youll be part of the Marketing Operations team, which plays a crucial role in managing the Medical, Legal, and Regulatory (MLR) review processes . This team acts as the central hub for coordination, accuracy, and timely execution of marketing material reviews. With expertise in regulatory compliance and project management, the team ensures that every marketing asset is audit-ready and aligned with business goals. Collaboration across global, cross-functional teams drives continuous improvement and marketing excellence. Lets talk about the role We are seeking a detail-oriented and highly organized professional to manage the Medical, Legal, and Regulatory (MLR) review processes from submission through final approval and archival. You will serve as the key liaison for marketing materials, ensuring completeness, accuracy, and compliance throughout the review lifecycle. Your role will include tracking review progress, managing document control systems, and driving improvements using process data and metrics. Key Responsibilities: Serve as the primary point of contact for submitting marketing materials into the Medical, Legal, and Regulatory (MLR) review processes Review submissions for completeness, accuracy, and compliance before routing to appropriate stakeholders Track materials throughout the review cycle to ensure timely progress and approval Oversee uploading of approved files into document control systems, maintaining proper classification, version control, and audit readiness Partner with marketing teams to provide guidance on submission requirements and MLR expectations Monitor and report on process metrics such as review cycle times and volume to identify and implement continuous improvements Lets talk about you 7+ years of experience in marketing operations, regulatory compliance, or a related function Familiarity with asset management and review systems/tools (e.g., Workfront, Aprimo) is highly desirable Strong organizational and project management skills with the ability to manage multiple deadlines effectively Exceptional attention to detail and commitment to accuracy in process execution Excellent communication skills and proven ability to work collaboratively with cross-functional, global teams Joining us is more than saying yes to making the world a healthier place. Its discovering a career thats challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

What you will do The role is responsible for managing the R&D Veeva Vault Platform technical team that develops and implements technology strategies, solutions, and services to support Amgens Veeva Vault Platform. The role will be involved in defining Amgens Veeva Vault Platform strategy, guiding technology decisions, and ensuring that all implementations adhere to established architectural principles, Veevas and the Industrys standard processes. The ideal candidate will have a consistent track record of leadership in technology-driven environments, managing technology platforms, digital transformation initiatives, and have a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. This role demands the ability to drive and deliver against key organizational critical initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Develop and maintain the enterprise Veeva Vault Platform architecture vision and strategy, ensuring alignment with business objectives Responsible for fostering platform reliability and efficiency through streamlined release management & execution and establishing consistent DevOps & CI/CD framework Accountable for designing and building customizations & configurations on the Platform as per the business needs including, creating custom objects, fields, workflows and SDKs Responsible for strategizing Platform Integrations while adhering to consistent integration standards and patterns, designing integration workflows, building connectors, centralizing build & run and performing consistent DevOps model for integrations Identify and mitigate architectural risks, ensuring that the platform is scalable, secure, and resilient Maintain comprehensive documentation of the platform architecture, including principles, standards, user guides, and models Drive continuous improvement in the architecture by finding opportunities for innovation and efficiency Work with partners to gather and analyze requirements, ensuring that solutions meet both business and technical needs Perform impact assessments, clearly define AS-IS and TO-BE states, and recommend platform upgrades in accordance with the new features and functionalities released by Veeva Design platform architecture that can scale to meet growing business needs and performance demands Develop and maintain logical, physical, and conceptual data models to support business needs Establish and enforce data standards, governance policies, and best practices What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications. Basic Qualifications: Masters degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelors degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field Must-Have Skills: Solid understanding of Veeva Vault Platform and Veeva Vaults 6-8 years Global Pharmaceutical experience Have Team\People management experience Experience with system integration technologies like Mulesoft, Databricks, etc. Excellent knowledge of data model and governance Solid understanding of pharmaceutical operations and data management business processes Experienced in pharmaceutical regulations and specifications Experienced in GxP process Experience working in agile methodology, including Product Teams and Product Development models Proficiency in designing scalable, secure, and cost-effective solutions Can work late hours Can work with multiple teams to meet the business and collaborator needs Can lead and guide multiple teams to meet business needs and goals Have collaborator and team management skills Good-to-Have Skills: Strong solution design and problem-solving skills Solid understanding of technology, function, or platform Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Knowledge of Platform and Data Governance Professional Certifications: Veeva Vault Platform Administrator (mandatory) SAFe DevOps Practitioner (mandatory) SAFe for teams (preferred) Soft Skills: Should be able convert business requirements into technical requirements Excellent critical-thinking and problem-solving skills Good communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation skills

What you will do In this vital role in the Veeva Vault team you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Possesses strong rapid prototyping skills and can quickly translate concepts into working code. Lead day to day operations and maintenance of Amgens R&D Veeva Vaults and hosted applications. Stay updated with the latest trends, advancements and standard process for Veeva Vault Platform ecosystem. Design, develop, and implement applications and modules, including custom reports, SDKs, interfaces, and enhancements. Analyze and understand the functional & technical requirements of applications, solutions and systems, translate them into software architecture and design specifications. Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software following IS change control and GxP Validation process while exhibiting expertise in Risk Based Validation methodology. Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. Maintain detailed documentation of software designs, code, and development processes. Work on integrating with other systems and platforms to ensure seamless data flow and functionality. Stay up to date on Veeva Vault Features, new releases and standard processes around Veeva Platform Governance. Basic Qualifications: Masters degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelors degree and 3 to 5 years of Computer Science, IT or related field experience OR Diploma and 7 to 9 years of Computer Science, IT or related field experience Functional Skills: Must-Have Skills: Experience with Veeva Vault Platform and Products, including Veeva configuration settings and custom builds. Strong knowledge of information systems and network technologies. 6-8 years of experience working in global pharmaceutical Industry Experience in building configured and custom solutions on Veeva Vault Platform. Experience in managing systems, implementing and validating projects in GxP regulated environments. Extensive expertise in SDLC, including requirements, design, testing, data analysis, creating and managing change controls. Proficiency in programming languages such as Python, JavaScript etc. Solid understanding of software development methodologies, including Agile and Scrum. Experience with version control systems such as Git. Preferred Qualifications: Familiarity with relational databases (such as MySQL, SQL server, PostgreSQL etc.) Proficiency in programming languages such as Python, JavaScript or other programming languages Outstanding written and verbal communication skills, and ability to translate technical concepts for non-technical audiences. Experience with ETL Tools (Informatica, Databricks). Experience with API integrations such as MuleSoft. Solid understanding & Proficiency in writing SQL queries. Hands on experience on reporting tools such as Tableau, Spotfire & Power BI. Professional Certifications: Veeva Vault Platform Administrator or Equivalent Vault Certification (Mandatory) SAFe for Teams (Preferred) Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

What you will do In this vital role you will we are seeking a highly skilled Associate IS Bus Sys Analyst to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Maintain existing code and configuration: Support and maintain SaaS applications Development & Deployment: Develop, test, and deploy code based on designs created with the guidance of senior team members. Implement solutions following standard methodologies for code structure and efficiency. Documentation: Generate clear and concise code documentation for new and existing features to ensure smooth handovers and easy future reference. Collaborative Design: Work closely with team members and collaborators to understand project requirements and translate them into functional technical designs. Code Reviews & Quality Assurance: Participate in peer code reviews, providing feedback on consistency to standard methodologies, and ensuring high code quality and maintainability. Testing & Debugging: Assist in writing unit and integration tests to validate new features and functionalities. Support fix and debugging efforts for existing systems to resolve bugs and performance issues. Perform application support and administration tasks such as periodic review, manage incident response and resolution, and security reviews. Continuous Learning: Stay up-to-date with the newest technologies and standard methodologies, with a focus on expanding knowledge in cloud services, automation, and secure software development. What we expect of you Must-Have Skills: Solid technical background, including understanding software development processes, databases, and cloud-based systems. Experience configuring SaaS applications (such as Veeva). Experience working with databases (SQL/NoSQL). Strong foundational knowledge of testing methodologies. Good-to-Have Skills: Understanding of Veeva Quality Vault/ALM/KNEAT. Curiosity of modern technology domain and learning agility Experience with the following technologies: Veeva Vault, MuleSoft, AWS (Amazon Web Services) Services (DynamoDB, EC2, S3, etc.), Application Programming Interface (API) integration and Structured Query Language (SQL) will be a big plus. Superb communication skills, with the ability to convey complex technical concepts. Qualification: Bachelors Degree and 0 to 3 years of experience in software development processes, databases, and cloud-based systems Diploma and 4 to 7 years of experience in software development processes, databases, and cloud-based systems

Sr Associate IS Organizational Effectiveness RIM_PromoMats What you will do In this vital role you will coach who facilitates team with Scrum events, processes, and supports teams in delivering value for Veeva Vault Team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, handling risks and dependencies, and driving relentless improvement. The Scrum master help adapt SAFe to the organizations needs, standardizing and documenting practices. The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience Roles & Responsibilities: Lead and handle product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team. Capture the voice of the customer to define business processes and product needs Collaborate with business partners, Architects and Engineering teams to prioritize release scopes and refine the Product backlog Lead and facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Clearly express features in User Stories/requirements so all team members and partners understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Stay focused on software development to ensure it meets requirements, providing proactive feedback to partners Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, requirement validation, and user acceptance Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement Basic Qualifications: Masters degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelors degree and 3 to 5 years of Computer Science, IT or related field experience OR Diploma and 7 to 9 years of Computer Science, IT or related field experience Functional Skills: Must-Have Skills: 6-8 years of experience working in global pharmaceutical Industry Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager Vault etc. Preferred Qualifications: Proficiency in automation tools and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodologies. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile etc.). Professional Certifications: SAFe for Teams (preferred) Veeva Vault Platform Administrator (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills.

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Job Location-- Noida/Gurgaon/Hyderabad/Kolkata/Bangalore/Mumbai/Pune/Chennai Develop tailored Veeva CRM solutions that address specific business needs and align with organizational goals. • Work closely with business analysts, stakeholders, and other technical teams to gather requirements and translate them into technical specifications. • Oversee the implementation and configuration of Veeva CRM, ensuring a seamless deployment in line with industry best practices. • Provide expert guidance on data management, system integrations, and any necessary system upgrades. • Create and maintain comprehensive documentation of system architecture, processes, and configurations for future reference. • Support regulatory compliance initiatives, ensuring adherence to data governance policies. • Co-ordinate with business and technical teams for Veeva CRM and integration • Experience in working with the Life Science industry and understanding of Veeva CRM applications • POC from the project team for customer • Ability to address salesforce platform specific questions and work with the integration team to support the build integrations, Veeva (CRM) integrations, and API client integrations. • To be able to work on current problems while thinking of future solutions. • Ability to drive creative and efficient use of technology and thrive in a team environment. • Highly skilled technologist who can strategize the full lifecycle of product production from conception through to release. • You have strong communication skills and can translate technical concepts to non-technical terms and partners. • Strong knowledge of Veeva CRM and Veeva Vault Promomats. Qualifications we seek in you! Minimum Qualifications / Skills Extensive experience in CRM architecture, implementation, and integrations, with a focus on Veeva CRM. • Strong knowledge of Veeva CRM architecture and related integrations. • Solid understanding of data management, compliance, and governance standards in the pharmaceutical industry. • Excellent communication skills to interact effectively with business stakeholders, technical teams, and other organizational levels. Preferred Qualifications/ Skills BTech/MCA/BE/BSC/Any Graduation Veeva CRM Certified Veeva Vault Certified

Roles & Responsibilities: Collaborate with System Architects and Product Owners to manage business analysis activities for Veeva - Site Collaboration and Veeva Vault Study Training systems, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Collaborate with Veeva - Site Collaboration and Veeva Vault Study Training business partners, Amgen Engineering teams and Veeva consultants to prioritize release scopes and refine the Product backlog . Support the implementation and integrations of Veeva - Site Collaboration and Veeva Vault Study Training systems with other Amgen systems. Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog . Ensure Acceptance Criteria and Definition of Done are well-defined. Stay focused on software development to ensure it meets requirements, providing proactive feedback to customers. Develop and implement effective product demonstrations for internal and external partners . Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements. Identify and manage risks associated with the systems, requirement validation, and user acceptance. Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users. Ensure operational excellence, cybersecurity, and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement . What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master's degree with 4 - 6 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Bachelor's degree with 6 - 8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies Preferred Qualifications: Experience with Agile software development methodologies (Scrum). Good communication skills and the ability to collaborate with senior leadership with confidence and clarity. Strong knowledge of clinical trial processes especially Site Collaboration and Study Training process. Familiarity with regulatory requirements for Clinical Trials (e.g. 21 CFR Part11, ICH ). Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA. Good-to-Have Skills: Familiarity with Veeva Clinical Platform, especially Veeva - Site Collaboration and Veeva Vault Study Training systems . Experience in managing product features for PI planning and developing product roadmaps and user journeys. Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions. Technical thought leadership. Able to communicate technical or complex subject matters in business terms. Jira Align experience. Experience with AWS Services (like EC2, S3), Salesforce, Jira, and API gateway, etc. SAFe for Teams certification (preferred). Certifications in Veeva products (Preferred). Certified Business Analysis Professional (Preferred). Soft Skills: Able to work under minimal supervision . Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams . High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills.

Roles & Responsibilities: Design, Build and maintain integrations between Veeva Vault - Clinical Operations and other applications in the Clinical Operations ecosystem. Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a customer concern point and facilitating communication when service commitments are not met Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle using Scaled Agile Framework (SAFe) Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Contribute and define business outcomes + requirements, technology solutions, and services. Participate in collaborator and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery. Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services. Facilitate standard process sharing, ensuring ongoing alignment with the Technology & Digital strategy. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate Degree OR Masters degree with 4 - 6 years of experience in Business, Engineering, IT or related field OR Bachelors degree with 6 - 8 years of experience in Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Business, Engineering, IT or related field Preferred Qualifications: Solid experience in implementing and managing application integrations using technologies such as MuleSoft. Experience on Veeva Vault Clinical Operations applications. Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Experience with version control systems like Git. Good understanding of cloud platforms (e.g., AWS, GCP, Azure) and containerization technologies (e.g., Docker, Kubernetes) Good-to-Have Skills: Extensive experience in the software development lifecycle. Experience with software DevOps CI/CD tools, such Git, Jenkins, Linux, and Shell Script. Experience using and adoption of Scaled Agile Framework (SAFe). Strong analytic/critical-thinking and decision-making abilities. Broad working knowledge of key IS domains and layers. ITIL (preferred) Scaled Agile Framework (SAFe) for Teams Veeva Vault platform (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams

What you will do Let's do this. Let's change the world. In this vital role you will responsible for leading the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a lead tester and validation expert with functional and system knowledge for Clinical Data Management, Interactive Response Technology (IRT) solutions. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Participate in requirement discussions related to the RBM / RBQM system(s) within Clinical Data Management and Interactive Response Technology (CDMIRT) product team, in order to create test scripts. Build test scripts per implementation project plan by working with various members of the product team and business partners. Conduct informal and formal testing, consolidate all the findings and coordinate with developer(s) and business partners to resolve all the issues. Perform regression testing to verify the changes do not negatively impact existing system functionality. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements. Identify and resolve technical challenges/bugs effectively. Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time. Support the creating and implementation of automated testing frameworks to improve efficiency and consistency. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate Degree OR Master's degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelor's degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field. Preferred Qualifications: Must-Have Skills: Knowledge of clinical trial processes specifically software validation processes. Experience with testing methodologies and automation practices. Experience with testing tools such as HP Application Lifecycle Management (ALM) and Veeva vault validation management. Experience in conducting testing activities in GxP systems. Good Problem-solving skills - Identifying and fixing bugs, adapting to changes. Good communication skills - Explaining design decisions, collaborating with teams. Experienced in Agile methodology. Good-to-Have Skills: Experience in Risk-based Approach to Change Management of Validated GxP Systems. Solid understanding of SQL scripting. Experience in RBM/RBQM systems. Experience with cloud-based technologies. Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFE for Teams certification (Preferred) Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills

The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves optimizing complex data systems supporting the health authority submission process, while ensuring compliance with regulatory regulations and guidance. The ideal candidate will have a strong background in system analysis and data science/AI in a regulated industry. Roles & Responsibilities: Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory requirements. Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices. Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives. Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates. Required Knowledge and Skills: Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors. 5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies. Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner. Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction. Familiarity with GxP requirements and systems validation. Life Sciences, Biotech or pharmaceutical industry experience. Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault Familiarity with global regulatory processes and standards. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. Basic Education and Experience: Bachelors degree and 2 years of directly related experience Associates degree and 6 years of directly related experience High school diploma GED and 8 years of directly related experience Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP 5+ years experience in data management, machine learning, or related fields.

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

Roles and Responsibilities Design, develop, and execute test plans for Salesforce Automation Testing/MS Dynamics CRM applications to ensure high-quality delivery. Collaborate with cross-functional teams to identify defects and implement fixes in a timely manner. Develop automated tests using Selenium Automation framework/MSCRM /Selenium Automation to improve testing efficiency. Participate in Agile development methodologies such as Scrum to deliver projects on time. Desired Candidate Profile 3-9years of experience in Salesforce Automation Testing/MS Dynamics CRM Proficiency in developing automated tests using Selenium Automation framework. Experience working on Veeva CRM/Vault implementation projects. Skill:Any One Required 1.Salesforce Automation Testing or 2.MSDynamics/MS CRM OR 3.Selenium Automation Testing -Java Coding

Develop and execute manual test scripts, create validation artifacts (IQ/OQ/PQ, UAT), perform dry runs and defect retests, trace requirements, collaborate with cross-functional teams, and support agile-based QA across Veeva Vault applications. Required Candidate profile Manual QA professional with 2+ years in Veeva Vault testing, experience in validation documentation, agile SDLC, pharma domain exposure. Preferably familiar with SFDC/Veeva CRM and basic automation

Team Leadership & Oversight Support and mentor a team of Clinical Data Specialists, promoting consistency, quality, and productivity. Collaborate on training plans, performance goals, and team development. Provide day-to-day guidance and technical support related to data issues. Help manage team capacity, workload distribution, and scheduling across studies. Foster effective collaboration with cross-functional teams. Data Management & Quality Assurance Accurate data maintenance, quality control, and discrepancy resolution in CTMS and EDC systems (e.g., RAVE, Veeva Vault, Clinical One, Inform). Review source documents for adherence to ALCOA-C principles and regulatory guidelines (GCP, HIPAA, FDA). Identify and resolve data inconsistencies and protocol deviations. Collaborate with clinical operations to ensure accuracy and completeness of source documentation. Support audit readiness through rigorous documentation practices and participation in quality reviews. Assist in creating source documents from protocols, CRFs, and lab manuals. Drive timely completion of data cleaning and database lock activities. Track and report key metrics for data quality and operational efficiency. Process Development & Compliance Develop SOPs, training guides, and implement process improvements. Identify inefficiencies and propose solutions to enhance workflow and team productivity. Participate in audits and collaborate on regulatory responses. Promote adherence to industry and internal standards. Cross-Functional Collaboration Serve as the point of contact for clinical data inquiries across assigned studies. Coordinate timelines and deliverables with project managers, monitors, and external stakeholders. Support all phases of the clinical study lifecycle from initiation to close-out. Qualifications and Experience Bachelor's degree in life sciences, health sciences, nursing, or a related field. Minimum 12 years of relevant experience, with at least 7 years in a Clinical Research Coordinator or Clinical Data Management role. Prior Managerial experience is a plus; must exhibit ability and willingness to take on supervisory responsibilities. Strong knowledge of CTMS (e.g., CRIO) and EDC systems such as RAVE, Veeva Vault, Clinical One, and Inform. Solid understanding of GCP, HIPAA, ALCOA-C, and clinical trial protocol standards. Must demonstrate ability to read, interpret, and operationalize clinical protocols. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Ability to work independently while building processes and guiding others. Willingness to align with US operating hours.