223 Veeva Jobs - Page 6

Hi , WE are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : SAS + CDB Programmer Mumbai (Job Code # 83) b) For Position in Pune Search : SAS + CDB Programmer Pune (Job Code # 84)

Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data lake and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : J Review Bangalore (Job Code # 87) b) For Position in Nagpur Search : J Review Nagpur (Job Code # 88)

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : EDC Veeva Mumbai (Job Code # 181) b) For Position in Pune Search : EDC Veeva Pune (Job Code # 182) C) For Position in Bangalore Search : EDC Veeva Bangalore (Job Code # 183)

Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to Inform or Medidata Rave database • Responsible & Accountable for the assigned study conduct activities, in clinical trials • Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. • Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. • To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). • SPOC for the study communications • Proactively highlight any risks associated with the study along with the mitigation plan. • Establish a partnership with the stakeholders at the operational level to work seamlessly to deliver the assigned project/activity as per timelines. • Identify process Improvement opportunities and ensure learning is shared • Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality. • Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas. • Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 C) For Position in Bangalore Search : Job Code # 186

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 95 b) For Position in Bangalore Search : Job Code # 98

Hi, We are hiring for ITES Company for SAS + CDB Programmer Role. Job description: Programming, specifically J Review, SQL, R and GitHub. Good to have Python. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data base and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Key Skills: a) Minimum 3 years of Experience in SAS CDB Programmers with R programming . b) Good to have Python knowledge c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 83

Hi We are Hiring for the job role of Medical Writer 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 To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writer Mumbai ( Job Code # 56) b) For Position in Pune Search : Medical Writer Pune ( Job Code # 57)

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: Any Graduation,BSc Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? Exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.-Extensive experience in database design, edit check programming, custom function programming and unit testing.-Experienced in various modules such as IVRS/RWS integration and Lab administration.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Any Graduation,BSc

Research & Development Consultant – Life Sciences and Health Join our team in Strategy consulting to find endless opportunities and solve our clients toughest" challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Life Sciences & Health, Industry Consulting, Capability Network I Areas of Work: Research & Development (R&D) | Level: Consultant | Location: Delhi, Gurgaon, Mumbai, Bangalore Years of Exp: 3 -6 years Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment spark your interest? Then, Accenture Strategy and Consulting is the right place for you to explore limitless possibilities. As a part of the Accenture Life Sciences practice , our 4000+ practitioners across the globe, help our clients make a meaningful impact on patients' lives through New Science, novel medical technologies and better collaboration. Together, let's deliver more effective, affordable, personalized patient outcomes. In this practice, you'll help drive our Life Sciences clients' strategy and business planning efforts, with the following initiatives: Support delivery of small to medium-size teams to deliver management consulting projects for global clients. Responsibilities may include strategy, implementation, process design and change management for specific modules Support efforts global sales team to identify and win potential opportunities within the practice. Provide industry expertise in various sub-segments of the LS industry Develop assets and methodologies , point-of-view, research or white papers for use by the team and larger community. Acquire skills that have utility across industry groups. Support on strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with client's business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Acquire skills that have utility across industry groups. Bring your best skills forward to excel in the role: Industry expertise with a global top pharmaceutical, medical devices or biotechnology firm Familiarity or expertise with assets or tools in business consulting such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on Good functional and domain knowledge with relevant experience in the same area Make presentations wherever required to a known audience or client on functional aspects of his or her domain Should have worked with multi-functional teams and cross-functional stakeholders Ability to solve complex business problems and deliver client delight Strong writing skills to build point of views on current industry trends Strong program management skills Good analytical and problem-solving skills with an aptitude to learn quickly Good communication , interpersonal and presentation skills Read more about us. Recent Blogs Qualifications Your experience counts! MBA from a Tier 1 institute or rich relevant industry experience 3 -6 years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences i ndustry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting ( R&D ), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, o perating m odel, b usiness p rocess mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite , pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable What’s in it for you? An opportunity to work on transformative projects with key G2000 clients Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything—from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions — underpinned by the world’s largest delivery network — Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients’ future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategy's services include those provided by our Capability Network – a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our Capability Network teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. For more information visit https://www.accenture.com/us-en/Careers/capability-network Accenture Capability Network | Accenture in One Word At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, come and be a part of our team .

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. • Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. • Associate should be able to manage communication with customers, track and ensure quality on-time deliverables • Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. • Experience in SDTM, ADAM & TLF • Experience in EDC & VEEVA • Expertise in Base and Advance SAS programming. • Expertise in developing macros and developing generalized programs. • Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. • Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. • Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 91 b) For Position in Nagpur Search : Job Code # 92

Hi , We are hiring for Leading ITES Company for SDTM Programmer Profile. Please go through the JD and we will get back to the relevant profiles. Job Description: Minimum 3 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Statistical Programmer Mumbai (Job Code # 208) b) For Position in Pune Search : Statistical Programmer Pune (Job Code # 209)

Let’s do this. Let’s change the world. In this vital role you 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 North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing strategic 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, regulatory affairs, and people management. Roles & Responsibilities: Manage various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers Serve as primary 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 the appropriate system Independently remain current on guidance (internal/external) and translate requirements into operational activities Effectively represent global submission management expertise on key projects and global workstreams Take part in the career and skills development of staff members 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 Represent departmental expertise on global work streams Initiate, lead and manage process development and improvement Lead information system and software update projects as well as ongoing system validations from a publishing perspective Develop and report metrics to senior management Provide technical support for regulatory systems Manage relationships with contributing functions and affiliates 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 and 4 to 6 years of directly related experience OR Bachelor’s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Strong 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. Subject Matter Expert for the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Expertise in the submission and maintenance of global Clinical Trial and Marketing Applications Expert knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Expert 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. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. 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

Experience in Life Sciences, Pharmaceuticals, or Healthcare industry. Agile and veeva vault

About The Role The Regulatory Data & Systems Manager will be responsible for facilitating system administration tasks and interpreting requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves managing and optimizing complex systems, ensuring compliance with regulatory regulations and guidance, and facilitating effective communication between various departments involved in the submission process. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs, and project management. Roles & Responsibilities: System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, 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. Proven Veeva Vault knowledge. 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 administering large scale enterprise systems in the Biotech/Pharmaceutical industry

The Senior Associate, Clinical Trial Submission Management, will help ensure the technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities. This vital role is assigned to one or more Amgen products under development to ensure clinical trial application approvals in the EU, delivering technical compliance with EU Clinical Trial Regulation No.536/2014 for every clinical trial submission dossier through close internal cross-functional collaboration. Roles & Responsibilities: Support assembly of the submission package and supportive documentation for regulatory deliverables, for the management of clinical trials Be the operational driver for Clinical Trial Submissions and notifications in the state-of-the-art regulatory document management system and maintain tracking systems. Be the critical technical coordinator for Clinical Trial Submissions and notifications through the EMA CTIS system, performing accurate and timely input of data and documents into the EMA Clinical Trial Information System for Clinical Trial Applications, Modifications and Notifications. Be the Single Point of Contact for incoming EMA CTIS notifications and alerts through daily monitoring and swift dispatching of incoming requests to cross functional teams. Be responsible for reviewing and triaging of Requests for Information from Health Authorities through CTIS to relevant cross functional teams. Ensure Requests for Information are tracked within the document management system. Recipient of notification of compliant events from Amgen Clinical Trial Registry System for input into CTIS within regulation timelines. Ensure efficient and timely data entry and communication of submissions to key process stakeholders. Submitting Clinical Trial Results to CTIS through the Marketing Authorisation Holder Access. Support Sponsor High Level Administrator within CTIS with access requests. Act as Subject Matter Expert for CTIS providing intelligence and expertise on technical submission requirements and system processes. Assist with definition, development, and implementation of processes to meet the evolving CTIS needs. Escalates, informs and resolves any issues that may impact submission process or timelines within CTIS. Build effective relationships and communication paths across local and functional organizations. Enable efficiencies and seamless execution across the EU region countries Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in teams Advanced knowledge of the regulations and regulatory guidance applicable to EU Clinical Trial Applications Advanced knowledge of the submission and maintenance of EU Clinical Trial Applications 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 Proven experience of working with clinical trial applications under CTR Basic Education and Experience: Master’s degree and 1-2 years of directly related experience OR Bachelor’s degree and 2-3 years of directly related experience OR Associate’s degree and 3-5 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with CTIS system

Let’s do this. Let’s change the world. In this vital role you 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 (non-Americas) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing strategic 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, regulatory affairs, and people management. Roles & Responsibilities: Manage various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers Serve as primary 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 the appropriate system Independently remain current on guidance (internal/external) and translate requirements into operational activities Effectively represent global submission management expertise on key projects and global workstreams Take part in the career and skills development of staff members 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 Represent departmental expertise on global work streams Initiate, lead and manage process development and improvement Lead information system and software update projects as well as ongoing system validations from a publishing perspective Develop and report metrics to senior management Provide technical support for regulatory systems Manage relationships with contributing functions and affiliates 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 and 4 to 6 years of directly related experience OR Bachelor’s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Strong 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. Subject Matter Expert for the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Expertise in the submission and maintenance of global Clinical Trial and Marketing Applications Expert knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Expert 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. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. 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

The Senior Associate, Global Submission Management – Americas, 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 North American 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 US, Canada and South America

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

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

As an Associate, Regulatory Data Management you will help ensure the compliance of our regulatory data via the smooth compliant flow of information across our systems and processes. Roles & Responsibilities: Provide support on maintaining our Regulatory Information Management (RIM) system. Create and archive clinical trial, marketing application submissions and health Authority correspondence within the organisation RIM system. Serve as a point of contact between regulatory representatives, CMC, safety, partners and the submission management team. Provide support on creating, running and analysing reports for data streamline projects. Provide support within data management global team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods. Adhere to Amgen processes, policies, guidelines, SOPs and training documentations. Required Knowledge and Skills: Highly motivated, organised, and detailed oriented team player. Familiarity with regulatory procedures and filings. Familiarity with global clinical and regulatory health authorities’ requirements e.g. FDA, EMA, MHRA etc. Preferred Knowledge and Skills: Working knowledge of the Veeva Vault platform is preferred Basic Education and Experience: Master’s degree and some directly related experience OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and 4 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP

The Regulatory Data & Systems Manager will be responsible for facilitating system administration tasks and interpreting requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves managing and optimizing complex systems, ensuring compliance with regulatory regulations and guidance, and facilitating effective communication between various departments involved in the submission process. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs, and project management. Roles & Responsibilities: System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, 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. Proven Veeva Vault knowledge. 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 OR Associate’s degree and 6 years of directly related experience OR 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 administering large scale enterprise systems in the Biotech/Pharmaceutical industry

The Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations. You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory information. As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to guide regulatory initiatives, ensuring the smooth adoption of new processes and system use. You will also play a key role in training and developing data standards, ensuring teams are equipped to meet the evolving demands of the regulatory landscape. Your expertise will help shape the future of regulatory operations by streamlining processes and driving compliance across global markets. Roles & Responsibilities: Responsible for maintaining data within the Regulatory Information Management (RIM) system Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system Serve as a Data Management SME within cross-functional collaborative initiatives Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives Provide support on creating, running and analysing reports for data streamline projects Develop and deliver training materials and presentations to a global audience Manage the protocol Amendment New Investigator (PANI) submission updates Manage 1572 forms for FDA submission Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods. Adhere to Amgen processes, policies, guidelines, SOPs and training documentations. Required Knowledge and Skills: Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance In depth understanding of the Veeva Vault system Good written and verbal communication skills Detail oriented Independent time management and prioritization skills Work efficiently with little support and minimal to no supervision Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect Critical thinking skills Appropriate software skills as required Strong analytical and problem solving, communication and presentation skills Good understanding of business complexity and project inter-dependencies Be a great teammate who can work effectively at all levels of an organization with the ability to influence others to move toward consensus Fluent in English, both in oral and written communication Experience in supporting projects / improvement initiatives Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM Be open to working in a dynamic environment embracing change as a constant and adopting new technologies Working in global teams and matrix organizations Able to follow through on tasks and motivate others to meet deadlines Basic Education and Experience: Master’s degree and 1-2 years of directly related experience OR Bachelor’s degree and 2-3 years of directly related experience OR Associate’s degree and 3-5 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with CTIS system

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.

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Clinical Database Developers:Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred.