223 Veeva Jobs - Page 4

Job responsibilities • Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. • Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. • Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. • Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports • Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. • Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. • Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. • Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. • Performs system integration activities, application updates, and user acceptance testing. • Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. • Assists in project meetings and actively contributes and participates in departmental review meetings. • Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. • Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. • Manages project resources, proactively alerting management of delivery and resourcing needs. • Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. Qualifications What were looking for • Bachelor’s degree preferred, or equivalent combination of related education and experience. • 5 years of experience, must have Data visualization experience in Spotfire/Tableau/PowerBI (Useful) • Experience with either Python/SAS/SQL. • Clinical background experience is a must, with preferred experience in iMedidata Rave & Veeva EDC. • Good to have Spotfire API experience/knowledge. • The ability to deal effectively with sponsors and internal customers at all levels. • Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. • Demonstrated experience in managing multiple priorities in a highly dynamic environment • Experience working in a matrix-structured environment is preferred • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail • Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. • Ability to travel as necessary (up to 25%)

Veeva Platform Engineer - Payments Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Purpose and Scope: As a Platform Engineer of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components Digital Capability and Digital Execution. Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. An Enterprise Business Platforms Engineer focuses on the development, deployment, and integration of software platforms that support our business processes and operations. This role involves a blend of technical expertise, business acumen, and a deep understanding of Veeva Clinical Platform. The goal is to ensure these platforms are optimized to support business goals, enhance efficiency, and drive growth. You will be at the forefront of implementing innovative solutions and will have the opportunity to work on cutting-edge technologies in your field. Essential Job Responsibilities: Platform Development and Configuration: Design, develop, and configure business platforms to meet the specific needs of our organization. This could involve programming, configuring settings, and integrating various software solutions. System Integration: Ensure seamless integration between different business platforms and systems (e.g., integrating CRM and ERP systems) to enhance data flow and business processes. Performance Monitoring and Optimization: Regularly monitor the performance of business platforms, identify bottlenecks, and implement optimizations to improve efficiency and user experience. User Support and Training: Provide technical support to platform users, resolve issues, and conduct training sessions to ensure users can effectively utilize the platforms. Initiative Execution: Actively participate in and contribute to various initiatives, applying your specialized skills to achieve the objectives and expected Value. Contribute to the ongoing realization of Value from these enterprise platforms through continuous integration and deployment. Collaboration: Work collaboratively with team members within the subdivision and across other digital and business units. Continuous Learning: Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in a specific area of expertise. Innovation: Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities. Reporting: Regularly report on the progress of the various Value Teams and outcomes to your Capability Lead and team members. Problem-Solving: Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions. Quality Assurance: Ensure the highest quality and consistency in the work delivered. Requirements Qualifications: Required Bachelors degree in relevant field, e.g., Computer Science, Data Science Minimum of 3-5 years of demonstrated relevant experience Demonstrated experience in developing and configuring in the Clinical Operations space using Veeva Vault Payments Business Process Understanding: Knowledge of Clinical operations business processes and how Vault Clinical supports these processes Strong analytical and problem-solving skills Ability to work effectively in a team environment Excellent communication skills, both written and verbal Agile and adaptable to changing environments and project scopes Present technical solutions based on the business requirement of the Clinical Veeva system. Able to support technical upgrade on quarterly basis by conducting technical impact assessment, addressing any technical issues, support the environment management, support testing, and document changes per the SLC process Manage user account, create roles, and support quarterly user access review request. Support system deliverables and provide technical feedback during internal and external Veeva Clinical system audit Work closely with the internal privacy and security team to assess Personal Information requests and act according per the privacy laws Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during the technical upgrade Preferred Veeva Admin Certification 1-3 years demonstrated experience with Veeva Vault Clinical Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery Technical Proficiency: Strong coding skills in relevant tools and technologies, e.g., Java, C++, Python, R, SQL is highly beneficial

Platform Engineer / Business Analyst - Veeva R&D Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Purpose and Scope: As a Platform Engineer of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components Digital Capability and Digital Execution. Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. As a business analyst, you will be responsible for understanding the needs of the end users, across commercial and medical business domains, and utilizing your knowledge and experience in Veeva R&D suite of products to demonstrate to end users how best to meet their requirements. You will then translate these requirements into well-defined user stories that the system engineers can rely on to develop, test, and deploy the required changes made to the systems. Essential Job Responsibilities: Business Requirements Analysis: Collaborate with business stakeholders to understand their needs, goals, and objectives. Analyse business processes and workflows to identify improvement opportunities and define requirements for solutions. Technical Specification Development: Translate business requirements into detailed technical specifications that guide the development of software applications, systems, or processes. Ensure that these specifications meet both the business needs and technical standards. Solution Design and Recommendation: Work with Digital and software development teams to design solutions that fulfil business requirements. Evaluate potential technical solutions for feasibility, cost-effectiveness, and alignment with business objectives. Stakeholder Collaboration: Serve as a liaison between business units and technical teams to ensure clear communication and understanding of project goals, requirements, and constraints. Facilitate meetings and discussions to gather feedback and consensus. Project Management Support: Assist in project management tasks, such as planning, scheduling, and tracking progress. Ensure that projects stay on track to meet deadlines and budget constraints. Testing and Quality Assurance: Participate in the testing of developed solutions to ensure they meet the defined requirements and standards. Assist in identifying and documenting bugs or issues for resolution. Training and Support: Develop training materials and provide support to users on new systems or applications. Ensure that end-users are equipped to use the new solutions effectively. Documentation: Create and maintain documentation related to business requirements, technical specifications, project plans, and reports to ensure knowledge is captured and shared. Requirements Qualifications: Required Minimum 3 years of experience in commercial and medical business analysis at a Life Science organization, focusing on Veeva R&D suite of products, including Vault Clinical, RIM, Quality, Safety. Knowledge and experience in R&D domains in Life Science / Pharma industry Demonstrated experience in business analysis, technical analysis, or a related area, demonstrating a track record of bridging business needs with technical solutions. Analytical Skills: Strong analytical and problem-solving skills to understand complex business issues and develop appropriate technical solutions. Experience in Agile methodology, DevOps, CI/CD principles and practices. Technical Knowledge: Good understanding of information technology, software development life cycles, and architectural frameworks. Communication Skills: Excellent verbal and written communication skills, with the ability to convey technical concepts to non-technical stakeholders and vice versa. Collaboration: Ability to work effectively in a team environment, collaborating with diverse groups of stakeholders, including business users, Digital professionals, and management. Attention to Detail: Precision in documenting requirements, specifications, and project details to ensure clarity and alignment with objectives. Adaptability: Flexibility to adapt to changing requirements, technologies, and project priorities. Preferred Veeva Certified Administrator Familiarity with programming languages, databases, and software development tools is beneficial. Certifications in Agile delivery methodologies (e.g., SCRUM, SAFe) Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery

The Manager, CSAR - Electronic Data Interchange and Acquisition What you will do Let’s do this. Let’s change the world. About The Role The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Interchange/Acquisition programming activities. The Manager, CSAR - Electronic Data Interchange and Acquisition will develop the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, 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 deliverables at the study and portfolio level. Manager, CSAR - Electronic Data Interchange and Acquisition 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 change management. The successful candidate will be a strong leader with demonstrated 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 deliverables. 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. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in writing the Data Acquisition Requirements Specification (DARS) document to specify metadata transfer requirements, setting up and testing RWS integration requirements supporting study closure with final data loads and transfer discontinuation, configuring data upload gateways between external vendors and Amgen. 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. 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 Experienced in collecting, maintaining, aggregating, and supporting data cleaning controls for external (non-EDC) data, importing clinical study data from various sources including central labs and imaging vendors. Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena Proven experience in managing teams General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related field with 9-13 years of experience. Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) 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 – 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

About The Role We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have 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. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). 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 Clinical trial databases and applications Study build and Edit check development Programming Languages ? Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with experience range of 9-13 years 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.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related discipline ? Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Manager, CSAR - SAS Edit Check Programmer What you will do Let’s do this. Let’s change the world. The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, 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 deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, 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 deliverables. 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. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. 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). 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 Proficient in SAS edit check programming Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline 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.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related field with6 to 8years of experience. Master’s degree and 4 to 6 years of experience. Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) 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.

Manager, CSAR – Custom function Programming What you will do Let’s do this. Let’s change the world. We are looking for a dedicated individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence collaborators and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have 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. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is aligned with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). 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 Clinical trial databases and applications Edit check development and Custom function programing Programming Languages Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent 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.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related field Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) 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, 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

Sr Associate IS Bus Sys Analyst What you will do Let’s do this. Let’s change the world. In this vital role you will leverages domain, technical and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans. This role involves working closely with business stakeholders, system owners and security analysts to ensure technical requirements are collated, documented and implement to ensure the success of our internal and external business partners. You will collaborate with the Product Owner and other Business Analysts to maintain an efficient and consistent process, ensuring the best quality deliverables from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Own expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and business problems and work with cross-functional owners to develop long-term solutions Maintain accurate documentation of configurations, processes, and changes Own technical solutions and maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree and 1 to 3 years of Life Science/Biotechnology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trial. E.g. Rave, CTMS, Veeva Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum), Change management and problem management Excellent problem-solving skills and a committed attention to detail in finding solutions. Good-to-Have Skills: Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Skilled in providing oversight and mentoring team members. Excellent analytical and gap/fit assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career 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.

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master’s degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor’s degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master’s degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process 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

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

Associate IS Bus Sys Analyst What you will do Let’s do this. Let’s change the world. In this vital role you will leverages domain, technical and business process expertise to provide exceptional end user support of Amgen’s external suppliers to ensure their effectiveness to deliver Amgen clinical trials for Amgen study teams. This role involves working closely with internal and external business stakeholder and support analysts to ensure rapid resolution of technical issues, performing route cause analysis and implementation of long-term preventative solutions. You will collaborate with the Product Owner and a team of other Business Analysts to ensure operational support excellence from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Oversee expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and process problems and work with multi-functional owners to develop solutions Maintain accurate documentation of configurations, processes, and changes Maintain detailed system and user documentation 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 with these qualifications. Basic Qualifications: Bachelor’s degree and 0 to 3 years of Life Science/Biotechnology/Information Systems experience OR Diploma and 4 to 7 years of Life Science/Biotechnology/Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trials. E.g. Rave, CTMS, Veeva Excellent problem-solving skills and a committed attention to detail in finding solutions Good-to-Have Skills: Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum) Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications : SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career 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.

PRODUCT QUALITY SPECIALIST What you will do Let’s do this. Let’s change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients. This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health. Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ) Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc. What we expect of you Basic Qualifications and Experience: Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or Master’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or Bachelor’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or Preferred Qualifications: Must-Have Skills: Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers Demonstrate proficiency in knowledge of cGMP and international regulatory expectations Strong scientific data management and organization skills with attention to detail Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills Good-to-Have Skills: Experience working virtually on a multi-functional team in a matrix environment across multiple time zones Expertise in computer applications such as Veeva, Spotfire, SHINY Expertise in MS Office (Word, Excel, PowerPoint, MS Teams) Soft Skills: Analytical and problem-solving skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills 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.

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. 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 and/or Device submission execution for Amgen products across phases of development, modality, and countries. The ROOTS2 staff member 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 and/or over seeing preparation of submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post-market 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 and/or Device submissions and related communications in the document management system Initiate and maintain CMC product and/or Device 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 Basic Qualifications: Doctorate degree OR Master’s degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience managing or hovering staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Experience in IVD, Device or Combination Product regulatory submission process 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

Sr Associate IS Engineer What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a Quality assurance tester and validation analyst for the Clinical Data Management and Interactive Response Technology (CDMIRT) product team. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Build test scripts per implementation project plan by working with various members of the product team and business partners. Conduct informal and formal testing, consolidate all the findings and coordinate with developer(s) and business partners to resolve all the issues Perform regression testing to verify the changes do not negatively impact existing system functionality Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Identify and resolve technical challenges/bugs effectively Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Support the creating and implementation of automated testing frameworks to improve efficiency and consistency What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Bachelor’s degree with 5-8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies Must-Have Skills: Knowledge of clinical trial processes specifically software validation processes Experience with testing methodologies and automation practices Experience with testing tools such as HP Application Lifecycle Management (ALM) and Veeva vault validation management Experience in conducting testing activities in GxP systems Good Problem-solving skills - Identifying and fixing bugs, adapting to changes Excellent communication skills - Explaining design decisions, collaborating with teams Experienced in Agile methodology Good-to-Have Skills: Experience in Risk-based Approach to Change Management of Validated GxP Systems Working knowledge of SQL scripting Experience in RBM/RBQM systems Experience with cloud-based technologies Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFE for Teams certification (Preferred) Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills 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.

Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in drug development. The Drug Development RD Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, Clinical data management, and analytics systems. 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 design implement various innovative solutions in the realms of Clinical data management, analytics Work in clinical data management and analytics area as part of strategy building, assessment and technology implementation project as business and data analyst Lead and participate in clinical business process discussions with clients, identify requirements and user stories Conduct online interviews and workshops to gather requirements to support the business needs of users Author high-level user stories and develop related tasks, acceptance criteria and review test cases Participate in clinical business process discussions with clients, identify requirements and user stories Work closely with project teams in creating Requirement Specifications, RTM and other project documents Plan and facilitate various Agile meetings and artefacts, including sprint planning, review retrospectives, daily stand-ups Perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules The ideal candidate will have a strong background in the project lifecycle, with experience in large and complex programs. They will have a track record of successfully managing people, and be able to provide support and escalation routes for queries, define and plan analysis deliverables, and agree on analysis approaches. Experience in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community is also essential. What Youll Bring Bachelors degree Pharma/ Bioinformatics / Medicine or related disciplines Master's degree in Business Analyst, Engineering or Science preferred. 5-10 years of experience working within Life Science Domain as solution architect / business analyst / data analys t is required. Experience of working in building solution around drug development - clinical data management areas like discrepancy management, clinical data repositories, clinical issue management, Operational data repositories, operational reports Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Experience working in Clinical data management area as BA or Subject matter expert Understand the end to end process for clinical data management and Analysis Exposure to clinical data coordination and clinical data management area. 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.

Skill required: Marketing Operations - Digital Asset Management (DAM) Designation: Digital Content Management Analyst Qualifications: Any Graduation/Bachelor of Pharmacy Years of Experience: 3 to 5 years What would you do? Review and comprehend diverse medical documents, including Journal Articles, Manuscripts, Abstracts, Posters, and Presentations. Demonstrate expertise in utilizing various referencing techniques and industry-standard references in the pharmaceutical field. Gain proficiency in taxonomy fundamentals to accurately organize and categorize medical information. Utilize metadata knowledge to enhance the organization and accessibility of medical documents. Develop a basic understanding of Veeva vault for effective management of digital assets. Ensure precision and compliance when disseminating medical information through digital marketing to Healthcare Professionals (HCPs). Take the lead in learning new skills, keeping up with the latest trends and advancements in the industry. Cultivate strong relationships with clients and internal stakeholders, fostering effective communication and collaboration. Clearly and effectively communicate medical information to both internal and external stakeholders, aligning with organizational goals. The role will be aligned to our Digital Asset Management team which is responsible for making management tasks and decisions surrounding the ingestion, annotation, cataloging, storage, retrieval, and distribution of digital assets. They act as a sort of librarian - archivist, organizer, and guardian of a company or organization s files, photos, video, audio, and other digital content. This is a highly collaborative role that can encompass responsibilities such as the proper management of usage rights and file permissions. What are we looking for? Digital Marketing Asset Management Content management Results orientation Detail orientation Adaptable and flexible Written and verbal communication Process-orientationBachelor's or Master's degree in pharmacy (B. Pharm/M. Pharm). 6 months to 1.5 years of experience in reviewing medical documents/Medical referencing. Proficiency in medical referencing techniques and awareness of industry standards. Exhibit proficiency in MS Office applications, including Excel, Outlook, and PowerPoint. Strong organizational skills and attention to detail. Effective interpersonal and communication skills. Ability to work well in a dynamic team environment. Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Any Graduation,Bachelor of Pharmacy

Project Role : Sales Origination Practitioner Project Role Description : Orchestrate and lead the entire origination process for a cross-client, cross service-group deal working with the CAL, the client team and relevant subject matter experts. Must have skills : Sales Pursuit Management Good to have skills : Veeva CRM, Veeva Vault Minimum 15 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Sales Lead, you will be responsible for identifying, owning professional services opportunities in Middle East markets working with our account teams and customers. Your typical day will involve working to progress on selling opportunities through the sales cycle working closely with cross-functional teams to achieve individual sales targets. Roles & Responsibilities: As a Sales Lead, Own and drive sales opportunities through deal origination to closure by demonstrating deep content in the areas of AMS, Cloud Migration (GCP, Azure, AWS), Data and AI and Platform (SAP, Oracle, SFDC, ServiceNow) enabled transformation, work with account teams to identify new selling opportunities and own deals from ideation to closure. Ownership of professional services selling from ideation through closure. Professional & Technical Skills: Must Have Skills:Deep content expertise in one of the areas mentioned above with prior delivery experience, Individual Sales Pipeline Management. Good To Have Skills:Sales Positioning for Professional Services in Technology, Sales Campaign and Marketing Strategy Proven track record of achieving sales targets and driving revenue growth. Strong understanding of sales processes and methodologies. Excellent Professional communication and interpersonal skills. Ability to work independently and as part of a team. Secondary Skill Deep knowledge of Veeva in the Life Sciences industry Additional Information: The candidate should have a minimum of 15 years of experience . This position is based in all the metro locations in India. Master degree in management or BTech or CA Qualifications 15 years full time education

Project Role : Sales Origination Practitioner Project Role Description : Orchestrate and lead the entire origination process for a cross-client, cross service-group deal working with the CAL, the client team and relevant subject matter experts. Must have skills : Sales Pursuit Management Good to have skills : NA Minimum 15 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Sales Lead, you will be responsible for identifying, owning professional services opportunities in Middle East markets working with our account teams and customers. Your typical day will involve working to progress on selling opportunities through the sales cycle working closely with cross-functional teams to achieve individual sales targets. Roles & Responsibilities: As a Sales Lead, Own and drive sales opportunities through deal origination to closure by demonstrating deep content in the areas of AMS, Cloud Migration (GCP, Azure, AWS), Data and AI and Platform (SAP, Oracle, SFDC, ServiceNow) enabled transformation, work with account teams to identify new selling opportunities and own deals from ideation to closure. Ownership of professional services selling from ideation through closure. Professional & Technical Skills: Must Have Skills:Deep content expertise in one of the areas mentioned above with prior delivery experience, Individual Sales Pipeline Management. Good To Have Skills:Sales Positioning for Professional Services in Technology, Sales Campaign and Marketing Strategy Proven track record of achieving sales targets and driving revenue growth. Strong understanding of sales processes and methodologies. Excellent Professional communication and interpersonal skills. Ability to work independently and as part of a team. Secondary Skill Deep knowledge of Veeva in the Life Sciences industry Additional Information: The candidate should have a minimum of 15 years of experience . This position is based in all the metro locations in India. Master degree in management or BTech or CA Qualifications 15 years full time education

The GN Song C&S Senior Manager, Lifesciences Join our team of Strategy & Consulting Global Network Song who solve customer facing challenges at clients spanning Sales, Service and Marketing to accelerate business change. Practice:Strategy & Consulting Global Network Song I Areas of Work:Life science industry, Commerce & Sales, Platform Enablement viz. Veeva CRM, Salesforce Health Cloud, etc. | Level:Senior Manager | Location:Bengaluru, Gurgaon, Mumbai, Chennai, Kolkata Hyderabad | Years of Exp:12+ years Are you passionate about scaling businesses using in-depth Customer Sales and Strategy techniques? Do you want to design, build and implement strategies to enhance business performance? Does working in an inclusive and collaborative environment spark your interest? Then, this is the right place for you! Welcome to a host of exciting global opportunities in Accenture GN Song team. The Practice A Brief Sketch The Global Network Song functional team is aligned to the S&C- Global Network division of Accenture and works with clients across its marketing, sales and services department. As part of the team, you will provide transformation services across key offerings like Marketing Transformation, Commerce & Sales and Advanced Customer Engagement. These services help our clients become living businesses by optimizing their marketing and sales strategies and thereby optimizing their cost to serve, thus improving revenue per customer. The Life Sciences & Healthcare Senior Manager position is within the Commerce & Sales practice of Accenture GN Song. The individual would work at the heart of the top global Life Sciences (Pharmaceuticals, Biotechnology and Medical Technology) organizations and would collaborate on innovative projects while bringing in deep industry knowledge to enhance Patient and HCP and consumer experience. You will work closely with our clients as Consulting Professionals who design, build and implement strategies that can help enhance business performance. As part of leading the project teams, you will drive the following:Consulting & Advisory service Lead a team responsible for designing, developing and implementing plans on Sales Transformation solutions across scope of sales strategy and sales operations, sales operating model design, channel strategy and design, HCP partner management, MR Portal Enablement, Consumer Engagement, Route-to-Market (RTM) Strategy, Optimization & implementation, sales force effectiveness, Territory Alignment, business process optimization, incentive compensation management including diagnostics and business case development. Work as an integral part of the client's sales / channel development organization. Work towards driving sales and revenue numbers with a structured, logical and dataoriented approach, conducting Market Opportunity Assessment. Work on diagnostics on client data and processes to understand gaps, in the current state processes to help improve client processes as part of future state recommendations Additional Engagement Opportunities Include:Market entry strategy development, Product launch strategy, Economics of Selling, Optimizing Return on Sales/ Channel Spends, Channel mix assessment and strategy, Sales channel optimization, Process Assessment & Improvisation, Sales Data Analysis, Marketing Planning, Assessment & Sales Enhancement Strategy, GenAI use cases specific to LS in sales and marketing. Sales & Business Development Generating new business engagements:Drive new business opportunities by identifying and pursuing new leads, defining GTM strategy, facilitate client discussions and presentations to drive new business and client relationships. Own and drive Sales transformation RFP/ RFI response coming in from Life Science customers for business transformation or platform enablement projects Practice Development Take on leadership role:Support overall growth of practice area through a combination of business development, talent management, oversight of delivery work, and thought leadership. Collaborate with Salesforce, Veeva, MS Dynamics, etc. business groups, to enable business capabilities with agility, velocity, and quality while optimizing costs. Lead and motivate teams with diverse skills and backgrounds. Manage and mentor talented teams of consultants and technologists supporting, providing input and guidance into the talent strategy and actively participate in engagement, capability development activities. Bring your best skills forward to excel at the role: Strong consulting and advisory experience in Life Sciences industry with deep industry knowledge and understanding of key trends. Deep understanding of Life Science processes, performance drivers & industry leading practices, regulatory and compliance requirements Experience in working as an advisory lead in designing next gen sales transformation solution on digital technologies like Veeva CRM and Salesforce Health Cloud, Data automation and AI tools. Adept with working knowledge of Gen AI based technologies and tools such as ChatGPT, Gemini, DallE, Midjourney, Anthropic, Amazon Bedrock, LLama etc. Capable of using GenAI within applications such as Salesforce, Adobe and MS Dynamics. Implementation experience of Gen AI will be an added advantage. Seasoned professional with significant experience working on a large-scale Business / Operational Transformation project with a significant focus on B2B/ enterprise clients. Strong program management/ people management skills Experience working with "C" level executives Can work in high-paced and complex projects and understand industry-specific sales processes, operations and functional needs Skills to manage stakeholder expectations Ability to work on business proposals from solutioning and effort estimation standpoint and to demonstrate solutions during client orals Excellent communications and presentation skills Performance and status reporting Problem solving and conflict management Ability to work effectively in a remote, virtual and global environment Qualifications Your experience counts! MBA from a premium institute A minimum of 12 15 years of progressive industry and consulting experience with minimum 8+ years of relevant experience in Life Science industry Global exposure is desirable. Working knowledge of Veeva CRM or Salesforce Health cloud and AI tools. Implementation experience is highly desirable. Experience in scoping and aid in designing platform solutions, and extensive experience in implementing it in projects. Demonstrated sustained client relations management experience at a C-suite level or operated at a senior management level in the industry role. Good To Have - Certification in Veeva CRM and/or Salesforce Health Cloud or any other relevant industry leading platform tools. Travel may be required for this role. The amount of travel will vary from 25% to 100% depending on business need and client requirements

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.

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 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: 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.

Entity :- Accenture Strategy & Consulting Team :- Global Network Data & AI Practice :- Life Sciences Title :- Ind&Func AI Decision Science Manager Job Location :- Delhi, Gurgaon, Mumbai, Bangalore About S&C - Global Network :- Accenture GN's Data & AI (AI Hub India) practice helps our clients grow their business in entirely new ways. Analytics enables our clients to achieve high performance through insights from data - insights that inform better decisions and strengthen customer relationships. From strategy to execution, Accenture works with organizations to develop analytic capabilities - from accessing and reporting on data to predictive modeling to outperform the competition. WHAT'S IN IT FOR YOU? An opportunity to work on high-visibility projects with top Pharma clients around the globe. 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 accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Qualifications What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter 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 the larger community. Acquire new skills that have utility across industry groups. Support 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, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for? Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process 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 Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process 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 Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills.

Entity :- Accenture Strategy & Consulting Team :- Global Network Data & AI Practice :- Life Sciences Title :- Ind&Func AI Decision Science Manager Job Location :- Delhi, Gurgaon, Mumbai, Bangalore About S&C - Global Network :- Accenture GN's Data & AI (AI Hub India) practice helps our clients grow their business in entirely new ways. Analytics enables our clients to achieve high performance through insights from data - insights that inform better decisions and strengthen customer relationships. From strategy to execution, Accenture works with organizations to develop analytic capabilities - from accessing and reporting on data to predictive modeling to outperform the competition. WHAT'S IN IT FOR YOU? An opportunity to work on high-visibility projects with top Pharma clients around the globe. 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 accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Qualifications What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter 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 the larger community. Acquire new skills that have utility across industry groups. Support 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, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for? Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process 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 Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process 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 Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills. Accenture is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, gender identity, or any other basis as protected by applicable law.