223 Veeva Jobs

Novo Nordisk Global Business Services (GBS) India Department – Commercial, GBS Are you an expert in content insightsDo you have experience in Veeva Vault and Power BIWe are looking for a Project Manager-Content Insights to join our team in the Commercial, GBS department at Novo Nordisk. If you are ready for a new challenge, read on and apply today for a life-changing career. The position As a Project Manager for Content analysis, you will act as an expert within analytics of content usage across digital channels by interpreting data, report to the business on important KPIs and the content performance for global and local teams. Drive and develop the agenda of a data-driven approach in Novo Nordisk internal content production hub by making sure insights are actionable and can drive change to the business. Your daily work-life will be as a sparring partner to relevant functions on primarily global but also local level on improving the content use and re-use. Ensuring a high-quality reporting foundation with deep understanding of digital content creation, reuse, localization and usage in Veeva Promo mats. Analyzing content module data, generating insights, and clearly communicate relevant findings to a broad audience to achieve maximum value of content across channels. Being a data specialist and showcasing deep knowledge about methodology, data availability and validity. Creating an overview of all dashboards and give advisory on content usage for colleagues and sharing dashboards to relevant stakeholders within the organization. Must have commercial mindset and basic understanding of business objectives. You are passionate about improving the digital experience through content excellence and ambitious about improving your skills within data analytics. Qualifications To be successful in this role, you should have the following qualifications: Degree or above in relevant area. Has +7 years of relevant pharma work experience. Candidate must be an expert within their field and have good understanding in VVPM particular within content insights and analytics of content usage. Substantial hands-on experience in front end visualization tools such as Power BI, QlikSense or similar. Sense of storytelling in building dashboards in tools such as QlikSense or PowerBI. Good presentation skills. Commercial understanding of KPIs. Ability to analyze data and provide evidence-based recommendations. Proactive and solution-oriented. Good time-management skills. Great interpersonal and communication skills. About the department The Commercial GBS department is responsible for creating insights to launch a product, market intelligence, forecasting, multichannel customer engagement planning, and global brand strategy and tactics. Our team consists of professionals in project management, brand management, brand communications, and life cycle management of products. Located at our headquarters, this fast-paced and dynamic department plays a crucial role in driving the success of our business.

Position Summary This position is part of the technical leadership in data warehousing and Business Intelligence areas. Someone who can work on multiple project streams and clients for better business decision making especially in the area of Lifesciences/ Pharmaceutical domain. Job Responsibilities o Technology Leadership – Lead guide the team independently or with little support to design, implement deliver complex cloud data management and BI project assignments. o Technical portfolio – Expertise in a range of BI and data hosting technologies like the AWS stack (Redshift, EC2), Snowflake, Spark, Full Stack, Qlik, Tableau, Microstrategy o Project Management – Get accurate briefs from the Client and translate into tasks for team members with priorities and timeline plans. Must maintain high standards of quality and thoroughness. Should be able to monitor accuracy and quality of others' work. Ability to think in advance about potential risks and mitigation plans. o Logical Thinking – Able to think analytically, use a systematic and logical approach to analyze data, problems, and situations. Must be able to guide team members in analysis. o Handle Client Relationship, P&L – Manage client relationship and client expectations independently. Should be able to deliver results back to the Client independently. Should have excellent communication skills. Education BE/B.Tech Master of Computer Application Work Experience Minimum of 5 years of relevant experience in Pharma domain. TechnicalShould have 15 years of hands on experience in the following tools Must have working knowledge of toolsAtleast 2 of the following – Qlikview, QlikSense, Tableau, Microstrategy, Spotfire Aware of techniques such asUI design, Report modeling, performance tuning and regression testing Basic expertise with MS excel Advanced expertise with SQL FunctionalShould have experience in following concepts and technologies Specifics Pharma data sources like IMS, Veeva, Symphony, Cegedim etc. Business processes like alignment, market definition, segmentation, sales crediting, activity metrics calculation 0-2 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company1-3 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company3-5 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company3-5 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company Behavioural Competencies Project Management Communication Attention to P&L Impact Teamwork & Leadership Motivation to Learn and Grow Lifescience Knowledge Ownership Cultural Fit Scale of resources managed Scale of revenues managed / delivered Problem solving Talent Management Capability Building / Thought Leadership Technical Competencies AWS KnowHow Formal Industry Certification AWS Certified Cloud Practitioner Snowflake Data Engineering Data Governance Data Modelling Data Operations (Service Management) Data Warehousing & Data Lake Databricks Dataiku Formal Industry Certification Informatica_Cloud Data Warehouse & Data Lake Modernization Master Data Management Patient Data Analytics Know How Pharma Commercial Data - US Pharma Commercial Data - EU

12+ years of IT Experience 4+ years in Veeva Vault in combination with any of below combined skills Must Have combinations of Specialized application expertise in or either (Atleast 3 combinations of any three below), Veeva CRM Suite, Veeva Vault RIM - Regulatory Information Management, Veeva Quality, Veeva LIMS - Lab information Management systems, Veeva Vault - Med Inquiry, Veeva Clinical Operations, Veeva Promo Mats Should have worked in Veeva LSH/ Health cloud environment for 3+ Years in Projects Able to demonstrate solutions/walkthrough with business stakeholders Should have hands on in Estimation / Presentation/Document preparation Veeva Vault Architecture experience Technical Expertise in Veeva Vault

QUALIFICATIONS Education: Advanced degree in Life Sciences, Pharmacy, or related field Experience: 15+ years in regulatory affairs, including 5+ years leading global teams in biopharmaceuticals. Proven track record in NDAs/BLAs for novel therapies (ophthalmology/metabolic disorders preferred). Expertise in FDA/EMA interactions, including Pre-NDA meetings and Advisory Committees. Skills: Proficiency in clinical trial design, statistical analysis, and regulatory writing. Familiarity with eQMS tools (Veeva, TrackWise) and regulatory intelligence platforms. Global Regulatory Strategy & Submissions Develop and execute regulatory strategies for novel biologics, including pre-IND meetings, orphan drug designations, and accelerated approvals. Lead NDA/MAA submissions for US FDA, EMA, and other agencies, ensuring compliance with ICH guidelines and regional requirements. Oversee clinical trial applications (CTAs/INDs) and provide input on study design, endpoints, and risk mitigation. Team Leadership & Cross-Functional Collaboration Manage a global team of regulatory professionals, fostering expertise in biologics, ophthalmology, and metabolic disorders. Partner with R&D, Clinical Development, and CMC teams to align regulatory plans with development milestones. Compliance & Audit Management Ensure adherence to GCP, GMP, and 21 CFR Part 11 standards during regulatory inspections and audits. Maintain submission timelines using eCTD formats and electronic submission gateways Team & Project Management Mentor QA leaders across sites, fostering a culture of quality and accountability. Design training programs on GMP/GLP updates, inspection readiness, and root cause analysis methodologies. Post-Marketing & Lifecycle Management Direct post-approval regulatory activities, including variations, renewals, and safety updates. Monitor evolving regulations (e.g., FDAs Novel Drug Approvals guidance) and implement proactive compliance measures.

Experience 4-8 Years of experience in specifications, design, develop and unit test and functionally validate clinical trial setup process edit check specifications and program or modify checks at study level within EDC SME (Subject Matter Expert) for all database related activities Familiar with custom functions within EDC system Prepare, test and implement postproduction changes as per study needs Work with leaders to resolve issues affecting the delivery of clinical trials Lead technology vendor oversight activities Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks

We are seeking a Clinical Programmer with expertise in JReview listings, dashboards, and visualizations to support clinical data review, safety monitoring, data validation and clinical data visualization, analysis, and reporting for clinical trials. Required Candidate profile 4+ Years of experience. MS SQL Server and R, R packages e.g., Tidyverse, ggplot2, dplyr, Pipeline creation, or Oracle, SAS, Python, Elluminate, BOXI, Spotfire, Tableau, Macros, RShiny, JReview, Plotly

5 years of experience working with Veeva CRM and Veeva Vault, including implementation, configuration, and support. In-depth knowledge of Veeva platform capabilities, including object configuration, workflow design, and data management. Strong analytical and problem-solving skills, with the ability to quickly diagnose and resolve technical issues. Excellent communication and interpersonal skills, with the ability to effectively collaborate with both technical and non-technical stakeholders. Experience working in regulated industries, such as pharmaceuticals or biotechnology, is preferred. Veeva certifications, such as Veeva CRM Administrator or Veeva Vault Administrator, are a plus. Familiarity with related technologies, such as Salesforce.com, is beneficial. Ability to work independently and manage multiple priorities in a fast-paced environment.

Sr Associate IS Analyst - Veeva Vault Release Engineer What you will do In this vital role in Amgen Veeva Release Management team and focuses primarily on change and release management, encompassing the planning, scheduling, and deployment of changes and releases across various Veeva Vault in Amgen. You will also provide essential support and expertise to key business users for smooth transition of the releases. Roles & Responsibilities: Support in development and implementation of the release management process for Amgen Veeva Vault platform. Manage release plans, including timelines, resources, and risk assessments. Collaborate with IT and business teams to facilitate smooth and efficient Veeva releases. Assess and plan for the impact of Veeva changes and releases on partners. Assists to develop and managing communication plans to engage Veeva partners and provide clear messaging. Support designing and delivery of training programs, offering ongoing support and coaching. Be part of change impact evaluations. Oversee planning, scheduling, and coordination of Veeva releases, ensuring alignment with change management strategies. What we expect of you We are all different, yet we all use our unique contributions to serve patients. 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. 4 - 5 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. Strong understanding of software development methodologies, including Agile and Scrum. Excellent written and verbal communication skills Preferred Qualifications: Familiarity with Agile methodologies for change management. Experience with change management tools and software. Knowledge of industry-specific regulations and standard processes, particularly in Life Sciences or Pharmaceuticals. Strong solution design and problem-solving skills Strong understanding of technology, function, or platform Ability to analyze client requirements and translate them into solutions Knowledge of Platform and Data Governance Professional Certifications: Veeva Vault Platform Administrator or Equivalent Vault Certification (Must-Have) SAFe for Teams (Preferred) Soft Skills: Excellent analytical and solving 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 can expect of us 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.

Specialist IS Bus Sys Analyst Veeva Release Analyst What you will do In this vital role you will Amgens Veeva Release Management team, collaborating with business partners, product owners, developers, and testers to develop release strategies. Your role is crucial in ensuring compliance and successful transitions of Veeva releases. You will also provide essential support and expertise to key business users for smooth transition of the releases. Roles & Responsibilities: Support in development and implementation of the release management process for Amgen Veeva Vault platform. Handle release plans, including timelines, resources, and risk assessments. Collaborate with IT and business teams to facilitate smooth and efficient Veeva releases. Assess and plan for the impact of Veeva changes and releases on collaborators. Assists to develop and leading communication plans to engage Veeva collaborators and provide clear messaging. Support designing and delivery of training programs, offering ongoing support and mentor. Be part of change impact assessment. Oversee planning, scheduling, and coordination of Veeva releases, ensuring alignment with organizational change strategies. 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: Experience with Veeva Vault Platform and Products, including Veeva configuration settings and custom builds. 6-8 years of experience working in global pharmaceutical Industry Experience in building configured and custom solutions on Veeva Vault Platform. Experience in handling systems, implementing and validating projects in GxP regulated environments. Extensive expertise in SDLC, including requirements, design, testing, data analysis, creating and handling change controls. Proficiency in programming languages such as Python, JavaScript etc. Solid understanding of software development methodologies, including Agile and Scrum. Excellent written and verbal communication skills Good-to-Have Skills: Familiarity with Agile methodologies for organizational change. Experience with organizational change tools and software. Knowledge of industry-specific regulations and standard methodologies, particularly in Life Sciences or Pharmaceuticals. Strong solution design and problem-solving skills Solid understanding of technology, function, or platform Ability to analyze client requirements and translate them into solutions Knowledge of Platform and Data Governance Professional Certifications Veeva Vault Platform Administrator or Equivalent Vault Certification (Must-Have) SAFe for Teams (Preferred) Soft Skills: Excellent analytical and fix skills. Strong verbal and written communication skills. Ability to work optimally with global, virtual teams. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills.

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 Let’s do this. Let’s change the world. In this vital role you will be a part of Amgen’s Learning & Development Product Team, working closely with business collaborators, product owners, business analysts, developers, and testers to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the vendor, software development and configuration teams. This position is ideal for individuals looking for a career in systems analysis and software solutions, providing opportunities for professional growth and development in a dynamic, collaborative environment. Roles & Responsibilities: Collaborate with partners and product team to elicit, document, and prioritize business requirements and turn them into user stories. Develop and update technical documentation, including standard operating procedures (SOPs), design documents, operational diagrams, manuals, and more. Develop process maps and flowcharts to visualize current processes and identify inefficiencies. Assist in the creation of test cases and test plans to ensure solutions meet business and regulatory GxP requirements. Collaborate with IT, HR, and other groups to ensure smooth operation of learning systems and integrated applications. Fix and resolve learning management system defects, integration errors, and reporting issues. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Bachelor’s degree and 0 to 3 years of Computer Science, IT or related field experience OR Diploma and 4 to 7 years of Computer Science, IT or related field experience. Functional Skills: Must-Have Skills: Strong knowledge of information systems and network technologies in the Human Resources – Learning & Development area. Strong problem-solving skills and the ability to analyze and fix complex system and data issues. Ability to produce clear and detailed documentation, including specifications, protocols, and process maps. Good-to-Have Skills: Experience with SumTotal, Workday, Cornerstone or other HR Learning platforms. Experience with validated GxP systems per FDA 21 CFR Part 11, pharma or other regulated industry. Familiarity with GxP validation management tools such as ALM, Veeva Vault Controlled Documents, etc. Experience with DevOps, software quality management and change management processes. Professional Certifications: SAFe – DevOps Practitioner (preferred). 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. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team oriented, with a focus on achieving team goals. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift rotation schedule. Candidates must be willing and able to work during evening or night shifts, as required based on product team structure and working hours. What you can expect of us 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, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

What you will do Let’s do this. Let’s change the world. In this vital role you will be a part of Amgen’s Learning & Development Product Team, working closely with business collaborators, product owners, business analysts, developers, and testers to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the vendor, software development and configuration teams. This role will be pivotal in ensuring compliance, efficiency, and innovation in the administration of the learning management system (LMS) and related system architecture, including reporting and integrations. This role will support continuous improvements and automation as well as apply technical expertise, validation experience, and a solid understanding of regulatory requirements. The role also demonstrates domain and business process expertise to drive ongoing improvements to meet Amgen’s regulatory and validation procedures. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of LMS systems. Roles & Responsibilities: Collaborate with system architects and product managers to handle business and systems analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs and translate to technology solutions. Work with the product owner to define scope and value for new developments. Facilitate the breakdown of epics into features and sprint-sized user stories and participate in backlog reviews with the development team. Collaborate with the product team, vendors, and other collaborators to prioritize release scopes and refine the product backlog. Clearly express features in user stories/requirements so all team members and customers 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 collaborators. Develop and implement effective product demonstrations for internal and external collaborators. Maintain accurate documentation of configurations, processes, and changes. Provide experienced technical support to meet objectives of quality, output and cost in developing, solve, standardizing and improving new and existing system capabilities. Prepare, implement, document, and report IS protocols in line with GxP and other regulatory requirements and standards. Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards. Partner with quality assurance, business and other technology teams to ensure alignment on objectives and testing requirements. Develop and manage test cases, protocols, and documentation. Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations. 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, Business, Engineering, IT or related field OR Bachelor’s 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. Functional Skills: Must-Have Skills: Strong knowledge of information systems and network technologies in the Human Resources – Learning & Development area. Solid understanding of software development methodologies, such as SDLC, Agile, and/or Scrum. Experience with designing and supporting integrated system architecture, including hosted applications, on-premise applications, custom applications, and reporting environments, such as AWS data lake platforms. Experience with SumTotal, Workday, Cornerstone or other HR Learning platforms. Good-to-Have Skills: Experience with validated GxP systems per FDA 21 CFR Part 11, pharma or other regulated industry. Familiarity with GxP validation management tools such as ALM, Veeva Vault Controlled Documents, etc. Experience with DevOps, software quality management and change management processes. Professional Certifications: SAFe – DevOps Practitioner (preferred) SAFe for teams (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 communication skills. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift rotation schedule. Candidates must be willing and able to work during evening or night shifts, as required based on product team structure and working hours. What you can expect of us 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, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Let’s do this. Let’s change the world. In this vital role you will iscover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. About the role Role Description: The Integrations Analyst is responsible for monitoring, updating and enhancing existing integration solutions using APIs (Application Programming Interfaces). The role involves connecting various systems, applications, and platforms through APIs to ensure smooth data exchange and interoperability between systems. The analyst will work with services technologies to create efficient integration solutions that meet business and technical requirements. Roles & Responsibilities: Monitor, update and enhance APIs for integrating internal and external systems ensuring scalability and security. Integrate third-party APIs, cloud services, and legacy systems with existing infrastructure and applications. Ensure APIs adhere to best practices for performance, reliability, and scalability. Transform data between various formats to ensure compatibility between source and target systems. Implement data validation and error handling during integrations 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: Master’s degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelor’s 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 Preferred Qualifications: Must-Have Skills Proficient in using MuleSoft Anypoint Studio to design, develop, and test integration flows Experience in designing and developing RAML based API's using Anypoint API Platform Proficiency with JSON, XML, SOAP, and REST, and protocols like HTTP, JMS, and FTP Integration experience with cloud services such as AWS, VEEVA or Salesforce Knowledge on security standards, including OAuth, SSL/TLS, and other authentication mechanisms Experience working in a DevOps environment using version control tools like Gitlab Strong understanding of software development methodologies, including Agile and Scrum Good-to-Have Skills: Strong expertise in Mulesoft or cloud technologies. Experience in API management, API design, enterprise integration. Experience with Databricks Professional Certifications: SAFe® for Teams certification (preferred) MuleSoft Certified Developer – Level 1 (optional) 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 Shift Information: This position requires you to work a later shift and will be assigned to the second shift. Candidates must be willing and able to work during evening shifts, as required based on business requirements. What you can expect of us 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, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com

Let’s do this. Let’s change the world. In this vital role you will discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. About the role Role Description: The Salesforce Analyst role is responsible for supporting, monitoring, maintaining and enhancing 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 the product team, the Salesforce Platform team, 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: Support, monitor, maintain and enhance existing business solutions using Salesforce Support and implement automation solutions using Flow Builder, Apex triggers, and Workflow Rules Support and implement and manage Salesforce security models, including profiles, permission sets, and role hierarchies Deploy code from sandbox environments to production using Salesforce Deployment Tools (Copado/ Salesforce CLI) Stay updated with the latest trends and advancements Work closely with product team, business team, and other stakeholders Design, develop, and implement applications and modules, including custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software Identify and resolve software bugs and performance issues Maintain detailed documentation of software designs, code, and development processes Customize modules to meet specific business requirements Work on integrating with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently 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: Master’s degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelor’s 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 Preferred Qualifications: Must-Have Skills Strong knowledge of information systems and network technologies 2+ years if hands on experience developing SFDC applications 2+ years of experience integrating Salesforce.com with other applications Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions Strong understanding of software development methodologies, including Agile and Scrum Experience working in a DevOps environment, which involves designing, developing and maintaining software applications and solutions that meet business needs. Good-to-Have Skills: Experience in Mulesoft or cloud technologies. Experience with Veeva MedComms Experience with Komodo Publication Planning Experience with Copado DevOps Professional Certifications: SAFe® for Teams certification (preferred) Salesforce Administrator (preferred) Salesforce Advanced Administrator (optional) Platform App Builder (optional) 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 Shift Information: This position requires you to work a later shift and will be assigned to the second shift. Candidates must be willing and able to work during evening shifts, as required based on business requirements. What you can expect of us 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, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com

What you will do Lets do this. Lets change the world. In this vital role you will play a critical role in shaping and delivering high-impact CRM solutions within the Salesforce and Veeva ecosystem. This position requires deep technical expertise in Salesforce and Veeva CRM along with a proven understanding of the pharmaceutical or life sciences industry. The ideal candidate will drive the design, development, and enhancement of scalable CRM solutions that align with evolving business goals and compliance standards. This role will also serve as a key technical resource across teams, for technical guidance, solution design and cross functional collaboration. Roles & Responsibilities: Design and deliver scalable Veeva CRM solutions built on the Salesforce platform to meet complex business requirements. Lead the development of custom functionality using Apex, Visualforce, Lightning Web Components (LWC), and Aura to enhance platform capabilities. Collaborate with teams to implement integrations between Veeva CRM, Veeva Vault, and third-party systems using REST/SOAP APIs and middleware tools. Influence technical direction and establish best practices for Salesforce and Veeva CRM development, ensuring adherence to industry standards and internal policies. Develop efficient and reliable automations using Apex, Flows, and other native tools to streamline and optimize business processes. Translate strategic business needs into clear technical solutions, working closely with business analysts, stakeholders, and engineering partners. Take ownership of the CRM solution design, ensuring flexibility, maintainability, and long-term performance. Maintain a strong focus on code quality, system reliability, security, and governance throughout the development lifecycle. Identify system gaps and improvement opportunities, proposing thoughtful enhancements to enhance value and efficiency. Solve and resolve complex technical issues related to custom development, integrations, and data workflows. Partner with Veeva/Salesforce CRM administrators, developers, and cross-functional teams to ensure smooth solution delivery and user adoption. Provide mentorship and technical direction to peers, contributing to team knowledge and development standards. 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 Preferred Qualifications: Must-Have Skills Solid understanding of Veeva CRM administration and Salesforce. Good understanding of software development methodologies, including Agile and Scrum Experience working in a DevOps environment, which involves designing, developing and maintaining software applications and solutions that meet business needs. Good communication skills, and excellent team leader with the ability to work effectively with multi-functional teams. Excellent problem-solving skills and attention to detail. Good-to-Have Skills: Solid experience with Salesforce Apex, Visualforce, and Lightning components is a plus. Knowledge of other Veeva platforms a plus Professional Certifications: Relevant certifications such as Veeva CRM and Salesforce Administrator (preferred) SAFefor 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

Manager, CSAR - Global Library What you will do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company’s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change. The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).. Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems Coordinating and providing programming support to Clinical Study Teams Maintaining standard business processes within GDO to ensure compliance to regulatory bodies Acting as a technical point of contact for systems deliverables on defined programs Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR) Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR) Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience Preferred Qualifications: Advanced degree in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Knowledge: Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Systems development lifecycle Programming Languages Project planning and management Quality management Regulatory filings and inspections Understanding of CDISC and SDTM Process improvement methodologies What you can expect of us 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, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Specialist IS Architect - Veeva Vault What you will do The role is responsible for developing and maintaining the overall data and IT architecture of Amgen’s Veeva Vault Platform . This role involves defining the architecture vision, creating roadmaps, and ensuring that IT strategies align with business goals, in Amgen’s R&D Veeva Vault Platform Agile Team. The role will be working closely with partners to understand requirements, develop architectural blueprints, and ensure that solutions are scalable, secure, and aligned with enterprise standards. The role will be involved in defining the Veeva Vault Platform Architecture strategy, guiding technology decisions, and ensuring that all implementations adhere to established architectural principles, Veeva’s and the Industry’s standard processes. Develop and maintain the Amgen’s 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 a 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 driving a 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 following 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 Provide domain expertise in Veeva Vault to the team, offering guidance on architecture, solution design, and implementation challenges. Provide hands-on technical leadership in resolving complex technical issues and ensuring smooth deployment and system integration 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: 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 Must-Have Skills Solid understanding of architecting and deployment strategies for Veeva Vault Platforms/Products, Expertise in system integration, including APIs, middleware tools, and data migration between Vault and other systems. Strong knowledge of Data Lake technologies like Databricks, etc. Experience in Mulesoft and Python 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 Can lead and guide multiple teams to meet business needs and goals Experience with cloud-based architectures, AWS, Azure, or similar environments. Good-to-Have Skills: Good Knowledge of the 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 (mandatory) SAFe for teams (preferred) Soft Skills: 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 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 can expect of us 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, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for EU, JAPAC, GCC, ZA

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: Bachelor’s degree and 2 years of directly related experience Associate’s 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

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us 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, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

What you will do In this vital role you will join a collaborative team implementing and supporting the Integrated case management systems on existing & future technologies. In this role, you will wear several hats including requirement gathering, implementation and analyze and resolve issues with case intake and data transfer across integrated systems. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient processing of data. Roles & Responsibilities: Design & development activities and deploy applications to support GxP system Evaluate tasks for automation feasibility using RPA (UiPath), intelligent automation (GenAI) tools. Engage with collaborators to understand business processes and difficulties where automation can reduce effort, increase accuracy, or improve turnaround time. Collaborate with business Subject Matter Experts and Technology Teams to develop test plans and scenarios to ensure robust validation of system updates, patches and new features. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Maintain detailed documentation of software designs, code, and development processes. Collaborate with business analysts and senior developers to propose automation use cases backed by clear value and impact. Basic Qualifications: Masters degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelors degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience. Functional Skills: Must-Haves Ability to design, develop, and maintain automation workflows using UiPath or other RPA tools (e.g., Automation Anywhere, Blue Prism). Knowledge of how RPA tools automate repetitive tasks, manage bot execution, handle exceptions, and log actions effectively. Experience with business analysis, writing user requirements and acceptance criteria in agile project management systems such as JIRA. Hands-on experience with the ITIL framework and methodologies like (Scrum). Experience in AI, ML, LLM & Python. Knowledge of SDLC process, including requirements, design, testing, data analysis, change control. Functional Skills: Good to Have Experience in HP ALM, JIRA, Visio and document management systems (e.g. Veeva). Experience with cloud platforms. Excellent problem-solving skills. Collaborative spirit and effective communication skills to seamlessly work in a multi-functional team. Experienced in managing GxP systems and implementing GxP projects. Ability to explain technical concepts to non-technical clients. 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. Team-oriented, with a focus on achieving team goals.

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

Job Information Job Opening ID ZR_2214_JOB Date Opened 20/04/2024 Industry Technology Job Type Work Experience 5-8 years Job Title Veeva CRM City Chennai Province Tamil Nadu Country India Postal Code 600004 Number of Positions 4 5 years of experience working with Veeva CRM and Veeva Vault, including implementation, configuration, and support. In-depth knowledge of Veeva platform capabilities, including object configuration, workflow design, and data management. Strong analytical and problem-solving skills, with the ability to quickly diagnose and resolve technical issues. Excellent communication and interpersonal skills, with the ability to effectively collaborate with both technical and non-technical stakeholders. Experience working in regulated industries, such as pharmaceuticals or biotechnology, is preferred. Veeva certifications, such as Veeva CRM Administrator or Veeva Vault Administrator, are a plus. Familiarity with related technologies, such as Salesforce.com, is beneficial. Ability to work independently and manage multiple priorities in a fast-paced environment.

Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process. What Youll Do You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. What Youll Bring Bachelors degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Masters degree in business analyst, Engineering or Science preferred. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred. Additional Skills Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences. Significant supervisory, coaching and hands-on project management skills. Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects. Willingness to travel to other global offices as needed to work with client or other internal project teams. In-silico, digital twin, and/or modeling experience.

Position: Clinical Programmer Experience: 4-9 Years Job Location: Remote Job Description: Minimum of 4+ years of experience in clinical programming for clinical data management in the pharmaceutical or CRO industry. Experience working with different EDC systems (e.g., Medidata Rave, Veeva, Oracle Clinical). Proficient in Python /SAS for data manipulation & automation. Experience in data cleaning , querying , and performing manual & automated data checks to ensure data integrity. Hands-on experience in data visualization and dashboard creation using Power BI , Spotfire , or other BI tools. Thorough knowledge of Data Collection and industry data standards . A person with bachelors or masters degree in computer science, Life Sciences, Biostatistics, or related field.