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4.0 - 6.0 years

6 - 10 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will work closely with Amgen Research partners and Technology peers to ensure that they technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role demonstrates scientific domain 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 for the software development teams. Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the Large Molecule Discovery technology ecosystem and ensure that the platform meets the requirements for data analysis and data integrity Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. Basic Qualifications: Master s degree with 4 - 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor s degree with 6- 8years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Preferred Qualifications: 5+ years of experience in implementing and supporting biopharma scientific software platforms. Functional Skills: Must-Have Skills: Proven expertise in a scientific domain area and related technology needs Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS/ELN platforms (e.g. Benchling), Discovery software tools (e.g. Geneious, Genedata Screener) and Instrument Automation and Analysis platforms Experience using platforms such as Spotfire, Tableau, Power BI, etc., to build dashboards and reports and understanding of basic data querying using SQL, Databricks, etc. Good-to-Have Skills: Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Knowledge of the antibody discovery design, make, test, and analyze cycle. Experience in AI and machine learning for drug discovery research and preclinical development Experience with leveraging LLM tools to accelerate software development processes. Experience with cloud (e.g. AWS) and on-premise infrastructure 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.

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1.0 - 3.0 years

2 - 6 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain 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 for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements software and infrastructure that enables the capture, analysis, storage, and report of pre-clinical and clinical omics (genomics, proteomics, transcriptomics etc.) data. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Translate complex scientific and technological needs into clear, actionable requirements for development teams Stay updated with industry trends, technological advancements, and scientific progress in Omics techniques, including data generation, processing, and analysis Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and milestones Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentation, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications and Experience: PhD with 1 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Biology/Bioinformatics or related field, OR Master s degree with 4 - 6 years of experience in Life Sciences, Computer Science, IT, Computational Biology/Bioinformatics or related field, OR Bachelor s degree with 6 - 8 years of experience in Life Sciences, Computer Science, IT, Computational Biology/Bioinformatics or related field, OR Diploma with 9+ years of experience in Life Sciences, Computer Science, IT, Computational Biology/Bioinformatics or related field Preferred Qualifications: 4+ years of experience in implementing and supporting biopharma scientific software platforms. Functional Skills: Must-Have Skills: Expertise in Omics data (Genomics, Proteomics, Transcriptomics etc.), oncology data Experience with bioinformatics tools and research workflows used to manage omics data Good understanding of database technology (e.g. RDBMS, Databricks) Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with cloud (e.g. AWS) and on-premise infrastructure Good-to-Have Skills: Experience using platforms such as Spotfire, Tableau, Power BI, etc., to build dashboards and reports Knowledge of handling GxP data and system validation (i.e. GCP) Understanding of AI and machine learning for drug discovery research and preclinical development In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Experience managing vendors, licenses in support of a Product team Knowledge of business analysis best practices, DevOps, Continuous Integration, and Continuous Delivery methodology Experience with platforms such as Benchling, or other LIMS Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills 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.

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6.0 - 11.0 years

9 - 13 Lacs

Hyderabad

Work from Office

Group Purpose The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the robust safety strategy and deliverables for each Amgen product. The group collaboratively drive excellence in patient safety by leading signal detection, management activities, and risk management practices, including Risk Evaluation and Mitigation Strategies (REMS). Through the definition and implementation of innovative policies, research initiatives, and best practices in safety science, the teams ensure comprehensive benefit-risk assessments, effective safety communications, and adherence to quality processes supported by measurable metrics. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance with worldwide regulations. Let s do this. Let s change the world. In this vital role you will oversee all signal management activities and staff in the Safety Sciences Team at the India site, working closely with the global teams while ensuring compliance with global regulations and company standards. This role requires a strong leadership attribute with a deep understanding of drug safety and pharmacovigilance, signal detection and management, safety data analyses, risk management and people leadership/ management, along with experience in innovation and technology. This staff member will provide leadership to the Safety Sciences Team, consisting of staff based in India working across multiple therapeutic areas and signal management, while reporting into the GPS AIN Lead. Key Activities Provide direction, strategy and leadership for signal detection and management activities at the India site Provide managerial leadership to the safety sciences team allowing appropriate prioritization of resources to achieve GPS goals. Regular communication with the global team to discuss product and/or process issues. Recruit and retain talented safety professionals. Provide coaching, mentoring, and development of staff Ensure staff are compliant with Amgen corporate and departmental training Disseminate relevant information to teams as appropriate Ensures smooth and collaborative interactions with all other Safety groups Provides relevant input on technical processes in the department and contributes to continuous improvement initiatives across GPS Accountable for delivery against goals assigned to group Participate in budget and headcount planning Establish effective, collaborative interfaces with partners outside of GPS e.g. tech to ensure GPS needs are being met with respect to signal management Lead or contribute to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal management What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Medical degree and 6 years of directly related experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. Minimum of 6 years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 3 years of functional management experience overseeing PV staff A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective Leadership skills and the ability to oversee multiple projects simultaneously Able to successfully manage workload to timelines Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources 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.

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1.0 - 3.0 years

1 - 5 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will implement the qualification and validation processes for the Enterprise Resource Planning (ERP) solutions and platform. This role is an expert in implementing validation plans and agile methodologies, ensuring compliance of the delivery teams with industry standards and regulatory requirements in a Life Sciences environment. Roles & Responsibilities: Lead all aspects of the qualification and validation deliverables of SAP ERP systems to ensure they meet industry standards and regulatory requirements. Create and implement detailed validation plans for SAP implementations, aligning with project timelines and deliverables. Collaborate with ERP projects and product teams, Quality Assurance, and business collaborators to define validation requirements, ensuring comprehensive testing and compliance. Develop and maintain critical validation documentation, including IQ, OQ, test scripts, and traceability matrices. Know the latest with GxP regulations, ensuring ongoing compliance and readiness for audits. 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 Computer Science, IT or related field experience OR Bachelor s degree and 3 to 5 years of Computer Science, IT or related field experience Diploma and 7 to 9 years of Computer Science, IT or related field experience Preferred Qualifications: Experience with Agile / Scaled Agile Framework (SAFe) methodologies for software delivery. Experience with validations tools such as CDOCs, ALM and JIRA. Professional Certifications Scrum Master (preferred) SAP certification (preferred) Soft Skills: Strong capability to analyze complex issues and develop effective solutions. Excellent verbal and written communication skills for collaborator interactions and documentation. High degree of precision in managing validation documentation and ensuring regulatory compliance. Ability to manage changing requirements and priorities effectively. Ability to focus on team collaboration and achieving project goals. 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.

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1.0 - 3.0 years

7 - 11 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will primarily focus on analyzing scientific requirements from Global Research and translating them into efficient and effective information systems solutions. As a domain expert, the prospective BA collaborate with cross-functional teams to identify data product enhancement opportunities, perform data analysis, troubleshoot issues, and support system implementation and maintenance. Additionally, it will involve development of data product launch and user adoption strategy of Amgen Research Foundational Data Systems. Your expertise in business process analysis and technology will contribute to the successful delivery of IT solutions that drive operational efficiency and meet business objectives. This role requires expertise in biopharma scientific domains as well as informatics solution delivery. Additionally, extensive collaboration with global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a solid background in the end-to-end software development lifecycle and be a Scaled Agile practitioner, coupled with change management and transformation experience. This role demands the ability to deliver against key organizational central initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Collaborate with geographically dispersed teams, including those in the US, EU and other international locations. Partner and ensure alignment of the Amgen India DTI site leadership and follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Function as a Scientific Business Analyst, providing domain expertise for Research Data and Analytics within a Scaled Agile Framework (SAFe) product team Serve as Agile team scrum master or project manager as needed Create functional analytics dashboards and fit-for-purposes applications for quantitative research, scientific analysis and business intelligence (Databricks, Spotfire, Tableau, Dash, Streamlit, RShiny) Support a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Translate scientific and technological needs into clear, actionable requirements for development teams Develop and maintain release deliverables that clearly outlines the planned features and enhancements, timelines, and milestones Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. What we expect of you Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience. Basic Qualifications: 3+ years of experience in implementing and supporting biopharma scientific research data analytics Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with data Collaborative spirit and effective communication skills to work seamlessly in a multi-functional team An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Familiarity with data analytics and scientific computing platforms such as Databricks, Dash, Streamlit, RShiny, Spotfire, Tableau and related programming languages like SQL, python, R Preferred Qualifications: Demonstrated expertise in a scientific domain area and related technology needs Understanding of semantics and FAIR (Findability, Accessibility Interoperability and Reuse) data concepts Experience with cloud (e.g. AWS) and on-premise compute infrastructure Experience with scientific and technical team collaborations, ensuring seamless coordination across teams and driving the successful delivery of technical projects Experience creating impactful slide decks and communicating data Ability to deliver features meeting research user demands using Agile methodology We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment. Professional Certifications SAFe for Teams certification (preferred) SAFe Scrum Master or similar (preferred) Soft Skills: Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Equal opportunity statement .

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4.0 - 6.0 years

8 - 12 Lacs

Hyderabad

Work from Office

Amgen India will be an integral part in driving growth & innovation, improving efficiency and creating enterprise value - supporting our mission To Serve Patients . The Amgen India Digital Technology & Innovation (DTI) Scientific Business Analyst (BA) role will primarily focus on analyzing scientific requirements from Global Research and translating them into efficient and effective information systems solutions. As a domain expert, the prospective BA collaborate with cross-functional teams to identify data product enhancement opportunities, perform data analysis, troubleshoot issues, and support system implementation and maintenance. Additionally, it will involve development of data product launch and user adoption strategy of Amgen Research Foundational Data Systems. Your expertise in business process analysis and technology will contribute to the successful delivery of IT solutions that drive operational efficiency and meet business objectives. This role requires expertise in biopharma scientific domains as well as informatics solution delivery. Additionally, extensive collaboration with global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle and be a Scaled Agile practitioner, coupled with change management and transformation experience. This role demands the ability to deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Collaborate with geographically dispersed teams, including those in the US, EU and other international locations. Partner and ensure alignment of the Amgen India DTI site leadership and follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Function as a Scientific Business Analyst, providing domain expertise for Research Data and Analytics within a Scaled Agile Framework (SAFe) product team Serve as Agile team scrum master or project manager as needed Serve as a liaison between global DTI functional areas and global research scientists, prioritizing their needs and expectations Create functional analytics dashboards and fit-for-purposes applications for quantitative research, scientific analysis and business intelligence (Databricks, Spotfire, Tableau, Dash, Streamlit, RShiny) Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain release deliverables that clearly outlines the planned features and enhancements, timelines, and milestones Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 6 to 8 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 10 to 12 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: BS, MS or PhD in Bioinformatics, Computational Biology, Computational Chemistry, Life Sciences, Computer Science or Engineering 3+ years of experience in implementing and supporting biopharma scientific research data analytics Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Excellent communication skills and experience creating impactful slide decks with data Collaborative spirit and effective communication skills to work seamlessly in a cross-functional team Familiarity with data analytics and scientific computing platforms such as Databricks, Dash, Streamlit, RShiny, Spotfire, Tableau and related programming languages like SQL, python, R. Good-to-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Understanding of semantics and FAIR (Findability, Accessibility Interoperability and Reuse) data concepts Understanding of scientific data strategy, data governance, data infrastructure Experience with cloud (e.g. AWS) and on-premise compute infrastructure Familiarity with advanced analytics, AI/ML and scientific computing infrastructure, such as High Performance Compute (HPC) environments and clusters (e.g SLURM, Kubernetes) Experience with scientific and technical team collaborations, ensuring seamless coordination across teams and driving the successful delivery of technical projects Ability to deliver features meeting research user demands using Agile methodology An ongoing commitment to learning and staying at the forefront of AI/ML advancements. We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment. Professional Certifications SAFe for Teams certification (preferred) SAFe Scrum Master or similar (preferred) Soft Skills: Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. 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. Equal opportunity statement

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0.0 - 3.0 years

3 - 5 Lacs

Hyderabad

Work from Office

This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain 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 for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms such as Laboratory Information Management Systems (LIMS) that enable the capture of lab workflows & experimental data and Electronic Lab Notebooks (ELN) that act as Amgen s System of Record ensuring data integrity and business continuity. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and landmarks Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Bachelor s degree with 0 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma with 4 - 7years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Preferred Qualifications: Experience with Agile software development methodologies (Scrum) Experience performing or enabling data capture and analysis from instruments in a research laboratory or vivarium Ability to communicate technical or complex subject matters in business terms Knowledge of business analysis standard processes, DevOps, Continuous Integration, and Continuous Delivery methodology Experience with cloud (e.g. AWS) and on-premise infrastructure Experience supporting ELN/LIMS platforms in biopharma Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills 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.

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4.0 - 6.0 years

4 - 8 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will be working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role uses scientific domain 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 for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Handle a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Support the technology ecosystem for small molecule discovery and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and milestones Identify and handle risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms that enable small molecule design, synthesis, testing, and analytics. You will implement and run chemistry-focused software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Basic Qualifications & Skills: Doctorate degree OR Master s degree with 4 - 6 years of experience in Computer Science, IT, Computational Chemistry/ Cheminformatics, Chemical Engineering or related field, OR Bachelor s degree with 6 - 8years of experience in Computer Science, IT, Computational Chemistry/ Cheminformatics, Chemical Engineering or related field, OR Diploma with 10 - 12 years of experience in Computer Science, IT, Computational Chemistry/ Cheminformatics, Chemical Engineering or related field or related field. Demonstrated expertise in a scientific domain area and related technology needs. Excellent problem-solving skills and a passion for solving complex challenges in drug discovery with technology and data. Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA. Experience with chemistry-focused software platforms (e.g., Revvity Signals Notebook, ACD/Labs, ChemAxon, Schr dinger LiveDesign/PyMOL/Maestro, BIOVIA Pipeline Pilot), compound registration systems, and AI tools for drug design. Preferred Qualifications & Skills: 5+ years of experience in implementing and supporting chemistry-focused software platforms in a biopharma setting. Experience with Agile software development methodologies (Scrum). Hands-on experience building BIOVIA Pipeline Pilot protocols. Ability to communicate technical or complex subject matters in business terms. Knowledge of business analysis standard methodologies, DevOps, Continuous Integration, and Continuous Delivery methodology. Knowledge of AI and machine learning use cases for drug discovery research. Experience with cloud (e.g. AWS) and on-premise infrastructure. Experience in establishing business partnerships and IS governance practices involving senior business partners. Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, remote teams High degree of initiative and self-motivation Ability to handle 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.

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1.0 - 3.0 years

2 - 6 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will be working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role demonstrates scientific domain 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 for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Run a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Support the technology ecosystem for small molecule discovery and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and landmarks Identify and handle risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Cultivate a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms that enable small molecule design, synthesis, testing, and analytics. You will implement and run chemistry-focused software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Basic Qualifications & Skills: Master s degree with 1 - 3 years of experience in Computer Science, IT, Computational Chemistry/ Cheminformatics, Chemical Engineering or related field, OR Bachelor s degree with 3- 5 years of experience in Computer Science, IT, Computational Chemistry/ Cheminformatics, Chemical Engineering or related field, OR Diploma with 7 - 9 years of experience in Computer Science, IT, Computational Chemistry/ Cheminformatics, Chemical Engineering or related field or related field Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for solving complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with chemistry-focused software platforms (e.g., Revvity Signals Notebook, ACD/Labs, ChemAxon, Schr dinger LiveDesign/PyMOL/Maestro, BIOVIA Pipeline Pilot), compound registration systems, and AI tools for drug design. Preferred Qualifications & Skills: 3+ years of experience in implementing and supporting chemistry-focused software platforms in a biopharma setting. Experience with Agile software development methodologies (Scrum) Hands-on experience building BIOVIA Pipeline Pilot protocols Ability to communicate technical or complex subject matters in business terms Knowledge of business analysis standard methodologies, DevOps, Continuous Integration, and Continuous Delivery methodology Experience with cloud (e.g. AWS) and on-premise infrastructure Experience in establishing business partnerships and IS governance practices Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, remote teams High degree of initiative and self-motivation Ability to handle 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.

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4.0 - 6.0 years

3 - 7 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will work closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain 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 for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality work from the team. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 4 to 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor s degree and 6 to 8 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 10 to 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Must-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS/ELN platforms such as Benchling, Revvity, IDBS, STARLIMS, Watson, LabVantage, etc. Experience using platforms such as Spotfire, Tableau, Power BI, etc., to build dashboards and reports Preferred Qualifications: 5+ years of experience in designing and supporting biopharma scientific software platforms Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Knowledge of bioanalytical workflows and/or biospecimen management Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Experience in establishing business partnerships and IS governance practices involving senior business collaborators Knowledge of business analysis standard methodologies, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills 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.

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5.0 - 9.0 years

4 - 8 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will work closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role demonstrates scientific domain 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 for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements and maintains the software and data ecosystem underpinning our Large Molecule Discovery pipeline. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality work from the team. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Function as a Scrum Master within the product team to help facilitate agile ceremonies Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the Large Molecule Discovery technology ecosystem and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Masters degree / Bachelors degree and 5 to 9 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field Preferred Qualifications: 3+ years of experience in designing and supporting biopharma scientific software platforms. Functional Skills: Must-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA. Experience in configuration and administration of LIMS/ELN platforms (e.g. Benchling), Discovery software tools (e.g. Geneious, Genedata Screener) and Instrument Automation and Analysis platforms Experience using platforms such as Spotfire, Tableau, Power BI, etc., to build dashboards and reports and understanding of basic data querying using SQL, Databricks, etc. Good-to-Have Skills: Experience in the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Knowledge of the antibody discovery design, make, test, and analyze cycle Experience in AI and machine learning for drug discovery research and preclinical development Experience with demonstrating LLM tools to accelerate software development processes Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Knowledge of business analysis standard methodologies, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) SAFe Scrum Master or RTE certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills 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.

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3.0 - 4.0 years

2 - 5 Lacs

Hyderabad

Work from Office

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Key Responsibilities: Project Coordination: Develop and maintain detailed project plans, timelines, and status reports. Coordinate meetings, workshops, and steering committees across time zones. Track deliverables, milestones, risks, and dependencies to keep projects on schedule. Operational Support: Streamline and document core business processes; identify and implement continuous improvements. Maintain accurate operations dashboards and KPIs, highlighting trends and anomalies. Manage vendor relationships, procurement requests, and compliance documentation. Cross-Functional Collaboration: Work closely with finance, HR, legal, and IT to facilitate project needs and organizational changes. Act as a liaison between regional offices to align on priorities, share best practices, and resolve issues. Prepare clear, concise communications for stakeholders at all levels. Data Analysis & Reporting: Gather, analyze, and present data to inform decision-making. Create executive-level presentations and summaries for leadership reviews. Monitor budget spend and escalate variances in a timely manner. Risk & Issue Management: Proactively identify potential roadblocks; recommend and implement mitigation strategies. Maintain an up-to-date risk/issues log and ensure accountability for resolution. Required Qualifications & Experience: Bachelor s degree in Business Administration, Project Management, Operations, or related field. 3-4 years hands-on experience coordinating projects and operations in a complex, global corporate environment. Proven ability to manage multiple simultaneous projects with competing deadlines. Core Skills & Competencies: Organizational Excellence: Meticulous attention to detail; thrives on structure and process. Go-Getter Mentality: Self-motivated, resourceful, and comfortable taking initiative without constant oversight. Communication: Excellent written and verbal skills; adept at tailoring messages for diverse audiences. Collaboration & Influence: Builds strong relationships; able to drive consensus across functions and geographies. Problem-Solving: Analytical mindset with the ability to break down complex challenges and propose practical solutions. Technical Proficiency: Skilled in MS Office Suite (especially Excel and PowerPoint); familiarity with project management tools (e.g., Asana, Jira, Smartsheet) and basic data visualization. Adaptability: Comfortable with ambiguity and changing priorities in a fast-evolving global setting. Preferred Attributes: Experience working with cross-cultural teams across multiple time zones. Certification in Project Management (PMP, PRINCE2, CAPM) or Operations (Lean Six Sigma). Proven track record of driving process improvements or cost-savings initiatives. Comfortable presenting to senior leadership and facilitating high-stakes workshops. 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.

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4.0 - 6.0 years

6 - 10 Lacs

Hyderabad

Work from Office

In this role you will be serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The QA Manager will support implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, supporting oversight and maintenance of external suppliers and contract manufacturers. You will be responsible for leading a team of quality professionals who will be maintaining and approving various quality documents including but not limited to: supplier documentation, analytical results investigations, CAPA and audit records. This role will involve collaboration with various Amgen teams to ensure seamless handoffs between teams Roles & Responsibilities: Oversee a team of approx. 6 staff, ensuring their activities and priorities are managed in a compliant and structured manner. Ensure team members are appropriately qualified and trained to perform needed activities per company procedures. Conduct goal setting, performance reviews, and compensation planning to align with organizational goals. Develop, implement, and maintain quality records in compliance with industry standards, GMP practices, and regulatory requirements. Continuously improve processes to enhance efficiency and quality, by applying lean principles and automation. Develop, monitor and report metrics to senior management to assess the health of the team s performance. Develop solutions that are thorough, practical, and consistent with functional objectives. Work cross functionally with various Amgen teams and stakeholders to ensure seamless transition of tasks and continuity across groups. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master s degree with 4 to 6 years of experience in quality management systems or a related field OR Bachelor s degree with 6 to 8 years of experience in quality management systems or a related field OR Diploma with 10 to 12 years of experience in quality management systems or a related field. Experience managing staff in a GXP environment Functional Skills: Must-Have Skills: Working foundation in quality assurance roles and proven team leader. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Experience in investigations, project management and trending and analysis Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing. Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations of a robust Quality Management System and documentation. 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.

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1.0 - 3.0 years

4 - 8 Lacs

Hyderabad

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Let s do this. Let s change the world. In this vital role you will be part of Amgen India Program Management Office (PMO) and reports to the Sr. Project Manager and supports the PMO team to track, organize, and monitor Amgen India site activation to ensure successful execution. This role acts as a liaison between business and technical teams, ensuring understanding of requirements and clear communication between team members. Roles & Responsibilities: Collaborate with leadership to ensure alignment with program goals, schedules, and budget. Track, organize, and monitor tasks and issues within Jira. This involves assigning tasks to team members, setting priorities, and ensuring that all tasks are completed on time. Facilitate the Scrum process and ensure that the team adheres to Agile principles. This includes organizing and leading Scrum ceremonies such as daily stand-ups, sprint planning, sprint reviews, and retrospectives. Collect, analyze, translate, and document business requirements into functional and non-functional specifications. Identify and escalate potential risks and help with mitigation strategies. Gather and interpret data to support decision-making and report on the progress of the transition Coordinate team meetings and manage meeting notes. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Program Management Office (PMO) professional we seek should possess these qualifications. Basic Qualifications: Master s degree and 1 to 3 years of project or program management experience OR, Bachelor s degree and 3 to 5 years of project or program management experience OR, Diploma and 7 to 9 years of project or program management experience Experience in project or program management. Solid understanding of project management software, such as Smartsheet, Power BI, Jira, and MS Office. Familiarization in project management principles, documentation, tools, and templates. Understanding creation and maintenance of executive dashboards and reports. Preferred Qualifications: Experience in multi-site project models and client communication skills. Additional certifications or experience in related project management tools. Negotiation Skills Soft Skills: Good time management and organizational skills. Strong collaboration skills. Effective communication with international teams and external partners. 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.

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4.0 - 9.0 years

10 - 15 Lacs

Hyderabad

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Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager, Global Regulatory Intelligence The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS - monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function. Key Responsibilities: Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes producing regulatory intelligence outputs that enable timely and efficient product filings worldwide - for example, compiling summaries of country-specific regulatory requirements , analyzing recent or upcoming changes in regulations, and providing recommendations to teams on filing strategies that maximize speed and compliance. The Senior Manager is accountable for delivering these assigned intelligence outputs to a high standard of quality. Processes & Systems Ownership: Oversee the efficient operation of specific intelligence-gathering systems and processes . The Senior Manager may be responsible for maintaining and improving tools or databases used for monitoring regulations and for ensuring that intelligence monitoring, analysis, and communication processes run smoothly in their area of ownership. They work in partnership with colleagues across GRAAS to refine these systems and may evaluate opportunities for automation or outsourcing to improve efficiency. Regulatory Analysis & Strategy Input: Analyze regulatory trends across Amgen s global footprint, identifying differences and commonalities in submission requirements between regions or product types. Based on this analysis, recommend practical approaches to dossier content and preparation that will satisfy local requirements while enabling globally efficient submissions. The Senior Manager provides this strategic input to global and local regulatory teams to influence filing strategies and ensure alignment with intelligence insights. They also identify major impending regulatory changes and help plan for regulatory change management efforts across the business (providing input to any large regulatory change projects). Cross-Functional Collaboration: Develop trusted relationships with cross-functional colleagues - including Global and Local Regulatory Affairs teams, Regulatory CMC, Policy staff, and others - to integrate intelligence into regulatory strategy and decision-making. The Senior Manager engages GRAAS policy staff, product strategy leads, and other experts to help establish priorities for intelligence activities and to execute on agreed deliverables. They often lead or coordinate cross-product regulatory projects (such as analyses to support multiple product filings) under the direction of the RI Director. In doing so, they ensure that intelligence findings are translated into actionable strategies and that any recommendations for policy advocacy (to promote global harmonization of requirements, for example) are communicated to the relevant teams. Continuous Improvement: Engage in continuous improvement of Regulatory Intelligence processes. The Senior Manager monitors progress against intelligence workplans and objectives, and conducts regular reviews with the RI Director to report on outcomes. They propose and implement enhancements to tools, methodologies, and workflows to increase the effectiveness of intelligence gathering and dissemination. For instance, they might help refine how regulatory information is captured and shared, contribute to templating requirements for future automation projects, or update procedures in response to lessons learned. Knowledge & Skills: Regulatory Expertise: A strong foundation in regulatory affairs is required . The Senior Manager should have recent global filing experience and in-depth knowledge of regulatory agency guidelines and procedures across major and non-major markets. An understanding of local regulatory processes and how they impact global submissions is important. The role demands the ability to synthesize complex regulatory information (from disparate sources and regions) and distill it into clear, actionable insights and recommendations. Project Management & Communication: Excellent project management skills are needed to handle multiple intelligence projects and deliverables. The Senior Manager must be able to track tasks, meet deadlines, and coordinate input from various contributors. Strong presentation and interpersonal communication skills are essential in order to effectively communicate intelligence findings to stakeholders and to represent the intelligence function in cross-functional discussions. The ability to influence without direct authority (especially when recommending changes to regulatory strategy based on intelligence) is a key soft skill for this role. Technical and Process Skills: Preferred candidates will bring experience in systems management and process management , as the role involves working with databases/tools and improving processes for information gathering. Familiarity with knowledge management practices and change management principles is also beneficial - for example, knowing how to systematically capture regulatory knowledge and support teams through major regulatory changes. An innovative mindset toward leveraging technology (including potential use of AI tools for intelligence) is a plus, given Amgen s interest in future automation of submission-ready content. Qualifications: Basic Qualifications: A combination of advanced education and relevant experience in life sciences/regulatory affairs. For instance, a Doctorate degree in a related field with ~4+ years of experience, Master s degree with ~3+ years, Bachelor s degree with ~5+ years, Associate s degree with ~10 years, or even a high school diploma/GED with ~12 years of directly related experience could be considered acceptable minimums. (These ranges align with internal job level guidelines for a role at the Senior Manager level.) Preferred Experience: Relevant industry experience in biopharmaceutical regulatory affairs (especially in regulatory intelligence, policy, or strategy functions) is highly desirable. The ideal candidate will have a track record of successfully managing regulatory information or contributing to regulatory submissions across multiple regions. Experience working on cross-functional teams and exposure to regulatory policy development or external advocacy would be a plus for this role. 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. .

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8.0 - 10.0 years

11 - 15 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will support the delivery of emerging AI/ML capabilities within the Commercial organization as a leader in Amgens Neural Nexus program. We seek a technology leader with a passion for innovation and a collaborative working style that partners effectively with business and technology leaders. Are you interested in building a team that consistently delivers business value in an agile model using technologies such as AWS, Databricks, Airflow, and Tableau? Come join our team! Roles & Responsibilities: Establish an effective engagement model to collaborate with the Commercial Data & Analytics (CD&A) team to help realize business value through the application of commercial data and emerging AI/ML technologies. Serve as the technology product owner for the launch and growth of the Neural Nexus product teams focused on data connectivity, predictive modeling, and fast-cycle value delivery for commercial teams. Lead and mentor junior team members to deliver on the needs of the business Interact with business clients and technology management to create technology roadmaps, build cases, and drive DevOps to achieve the roadmaps. Help to mature Agile operating principles through deployment of creative and consistent practices for user story development, robust testing and quality oversight, and focus on user experience. Become the subject matter expert in emerging technology capabilities by researching and implementing new tools and features, internal and external methodologies. Build expertise and domain expertise in a wide variety of Commercial data domains. Provide input for governance discussions and help prepare materials to support executive alignment on technology strategy and investment. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 8 - 10 years of experience in Information Systems experience OR Bachelor s degree with 10 - 14 years of experience in Information Systems experience OR Diploma with 14 - 18 years of experience in Information Systems experience Excellent problem-solving skills and a passion for tackling complex challenges in data and analytics with technology Experience leading data and analytics teams in a Scaled Agile Framework (SAFe) Good interpersonal skills, good attention to detail, and ability to influence based on data and business value Ability to build compelling business cases with accurate cost and effort estimations Has experience with writing user requirements and acceptance criteria in agile project management systems such as Jira Ability to explain sophisticated technical concepts to non-technical clients Good understanding of sales and incentive compensation value streams Technical Skills: ETL tools: Experience in ETL tools such as Databricks Redshift or equivalent cloud-based dB Big Data, Analytics, Reporting, Data Lake, and Data Integration technologies S3 or equivalent storage system AWS (similar cloud-based platforms) BI Tools (Tableau and Power BI preferred) Preferred Qualifications: Jira Align & Confluence experience Experience of DevOps, Continuous Integration, and Continuous Delivery methodology Understanding of software systems strategy, governance, and infrastructure Experience in managing product features for PI planning and developing product roadmaps and user journeys Familiarity with low-code, no-code test automation software Technical thought leadership Soft Skills: Able to work effectively across multiple geographies (primarily India, Portugal, and the United States) under minimal supervision Demonstrated proficiency in written and verbal communication in English language Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Intellectual curiosity and the ability to question partners across functions Ability to prioritize successfully based on business value High degree of initiative and self-motivation Ability to manage multiple priorities successfully across virtual teams 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.

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8.0 - 13.0 years

8 - 12 Lacs

Hyderabad

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Let s do this. Let s change the world. The Product Analyst position offers a unique opportunity to join a fun, innovative engineering team within the Enterprise Data Strategy and Engineering (EDSE) organization. You ll work on building next-generation capabilities and services in Data and AI using innovative open-source software, frameworks, tools, and cloud computing services. The role also emphasizes demonstrating these capabilities to support critical business operations and initiatives, ensuring alignment with organizational priorities. We are seeking a detail-oriented and analytical Product Analyst with a strong background in Business Intelligence (BI) and reporting to support data-driven decision-making across our product teams. You will be responsible for gathering requirements for transforming data into actionable insights, building dashboards, and collaborating with cross-functional teams to enhance product performance and user experience. You will work closely with business team and you will need to play a key role in the Go-to-Market (GTM) strategy, ensuring seamless product launches, aligning messaging with customer needs. Acting as the Voice of the Customer, you will collaborate internally within Product Management and with Product Engineering, and the GTM teams to drive product adoption and deliver optimal outcomes Help design, develop, and maintain BI dashboards and reports using tools like Power BI, Tableau, or Looker. Collaborate with business, product managers, engineers, and stakeholders to define KPIs and success metrics. Translate business requirements into technical specifications for reporting and analytics Customer Insights & Experience: Develop a deep understanding of both data and related metrics to help customer with best possible representation of reports and dashboards Engage directly with customers at key touchpoints, gaining insights into their interactions with BI reports and dashboards. Build and foster an active user community, facilitating knowledge-sharing and enhancing the adoption of data and AI products. Go-to-Market (GTM) Strategy: Collaborate with Product Management to implement comprehensive GTM strategies for data and AI products. Align GTM messaging and product positioning with organizational needs, enabling effective adoption and broader applicability of solutions Support the launch of new products and features, working closely with multi-functional teams to ensure GTM plans are well-executed and drive product adoption. Support & Advocacy: Provide Last Mile Support and Solutions on Demand for both data, ensuring prompt resolution of customer challenges and delivering a seamless user experience. Assist in user onboarding and training, ensuring users fully understand how to demonstrate the platform s data capabilities. Identify and develop brand ambassadors within the customer base to advocate for the product s unique benefits. Provide targeted support for unique business requirements, enabling seamless integration of data capabilities into broader operational frameworks Product Performance & Data Analysis: Monitor and analyze product performance metrics using advanced analytics to gain insights into customer behavior and product usage. Work closely with engineering, product management, and other teams to ensure the successful execution of product goals, focusing on data, analytics, and AI-driven innovations. The insights and optimizations from product analytics will ensure alignment with overarching business goals and operational priorities, supporting scalable and impactful outcomes. What we expect of you Any degree and 8 to 13 years of experience in relevant field Basic Qualifications: 8-13 years of experience in a product analyst role, especially with BI reporting and dashboards, and a focus on GTM execution. Worked with different BI tools such as Power BI, Tableau etc. Experience of working closely with data engineering. Experience in GTM strategy development and execution, with a track record of supporting product launches and ensuring right dashboards are provided. Strong skills in Excel and hands-on experience with Agile methodologies (Scrum/SAFe). Excellent communication and social skills, with the ability to work collaboratively with cross-functional GTM, product, and engineering teams. Knows SQL. Preferred Qualifications: Have worked on BI tools previously.. Familiarity with data transformations, visualizations, AI platforms, and cloud-based data solutions. Ability to work effectively across matrixed organizations and lead collaboration between data and AI teams. Passion for technology and customer success, particularly in driving innovative AI and data solutions. Experience in services or consulting related to data and AI products is a plus, and familiarity with biotech/pharma is beneficial. Soft Skills: Excellent analytical and solving skills. Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to handle 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.

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8.0 - 10.0 years

50 - 55 Lacs

Hyderabad

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Let s do this. Let s change the world. In this vital role the ideal candidate will have a proven track record of leadership and mentoring in technology-driven environment, with a strong focus within the Salesfore.com product lineup. The candidate should be a self-starter and have a strong passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have strong business analysis skills and technical background in end-to-end software development lifecycle. Proficiency in managing complex integration projects and ensuring compliance with privacy standards is essential. Roles & Responsibilities: Collaborate with business collaborators on end-to-end Commercial Marketing operations business process and translate business requirements into clear, actionable technical requirements for development teams Define and communicate the product feature vision, including both technical / architectural features and enablement, and end-user features, ensuring alignment with business objectives across multiple solution collaborator groups Collaborate with cross domain & multi-functional collaborators, including Commercial Marketing owners to design, implement, and manage features Create strategic roadmap for Commercial Marketing applications to ensure that the applications continue to align with business process requirements Work with Product Owners, Service Owners and developers/testers to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Leverage cutting-edge AI/ML and cloud technologies to address Commercial Marketing needs and shape the vision for the Commercial Marketing software ecosystem. Oversee the software development lifecycle using Scaled Agile Framework (SAFe) Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Collaborate with geographically dispersed teams, including those in the US and other international locations. Ensure communication of key performance metrics and analysis of unmet needs Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 8 - 10 years of experience in Business, Engineering, IT or related field OR Bachelor s degree with 10 - 14 years of experience in Business, Engineering, IT or related field OR Diploma with 14 - 18 years of experience in Business, Engineering, IT or related field Experience in implementation and management of integrated Salesforce.com platforms through the SDLC Experience in business requirement gathering and converting the requirements into a technical solution Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation. Familiarity with security requirements and standard methodologies for data at rest and in transit Success in mentoring and developing strong product analysts, business analysts, and developers Exceptional collaboration, communication and interpersonal skills to effectively manage collaborator relationships and build new partnerships. Preferred Qualifications: Health Cloud and Lifesciences Cloud hands on experience Working knowledge of integrations and tools such as Mulesoft Extensive experience in the software development lifecycle Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities Established business partnerships and IS governance practices involving senior business collaborators Broad working knowledge of key IS domains and layers Professional Certifications: Salesforce Marketing Cloud Consultant (preferred) Scaled Agile Framework (SAFe) for Teams (preferred) Salesforce.com Administrator (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams What you 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.

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8.0 - 10.0 years

13 - 18 Lacs

Hyderabad

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Let s do this. Let s change the world. The Release Train Engineer is a leader and coach who facilitates team / ART / SRT events, processes, and supports teams in delivering value. The role involves facilitating communication and collaboration among Clinical Trial Execution Technology Product teams, enable and manage Agile Release Train, ensuring alignment with the program vision, managing risks and dependencies, and driving relentless improvement. They also often participate in the Lean-Agile transformation, coaching leaders, teams, and Scrum Master/Team Coaches in the new mindset and processes. They help adapt SAFe to the organization s needs, standardizing and documenting practices Roles & Responsibilities: Lead and manage product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools. Lead and facilitate agile events including stand-ups, sprint/PI planning, sprint/PI reviews, retrospectives, demos and backlog refinement meetings to promote team collaboration. Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Collaborate with multi-functional teams to identify business requirements and develop solutions that meet customer needs. Work with Product Owners, Product and Solution Management, and collaborators to ensure strategy and execution alignment Help the scrum teams achieve delivery acceleration focused on business outcomes by reaching higher levels of scrum maturity Identify, escalate, and manage risks and dependencies across ART to ensure that they are addressed in a timely manner Coordinate with Services and support to schedule resolution of issues with released products Foster a culture of continuous improvement within the ART Train by leading retrospectives and encouraging innovation Monitor and report on the progress of the ART, ensuring transparency and alignment with solution objectives Lead and facilitate the PI planning event and ensure strategic and organizational readiness, leadership team preparedness and logistics management for planning readiness Manage and optimize the flow of value through the Agile Release Train using various tools, such as Program Kanban and other information radiators Lead and facilitate agile events and events such as Program Increment (PI) planning, pre and post PI Planning, Solution demos, and iteration planning, to ensure alignment and collaboration across teams Provide guidance and support to RTEs, Scrum Masters, and Product Management teams to help them deliver value effectively and adhere to Agile standard methodologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 8 - 10 years of experience in Computer Science, Business, Engineering, IT or related field OR Bachelor s degree with 10 - 14 years of experience in Computer Science, Business, Engineering, IT or related field OR Diploma with 14 - 18 years of experience in Computer Science, Business, Engineering, IT or related field Strong understanding of Agile methodologies, particularly the Scaled Agile Framework (SAFe) Prior experience with Agile project management tools, such as Jira, Confluence and Jira Align Experience in guiding teams through Agile events and ensuring adherence to SAFe practices and behaviors Excellent problem-solving skills and a passion for tackling complex challenges with data Collaborative spirit and effective communication skills to work seamlessly in a multi-functional team Preferred Qualifications: Deep understanding of DevOps and Test Automation Processes in software delivery Workshop facilitation and training experience Professional Certifications : Certified SAFe Scrum Master or similar (preferred) Certified SAFe RTE or similar (preferred) Certified SAFe STE or similar (preferred) Soft Skills: Excellent people and project management skills Ability to work collaboratively with cross-functional teams Ability to manage multiple priorities successfully Team oriented with a focus on achieving team goals 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.

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4.0 - 6.0 years

8 - 12 Lacs

Hyderabad

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Let s do this. Let s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and integration solutions in Clinical Trial Management, Monitoring, & Engagement (CTMME) product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting Veeva - Vault Clinical Operations to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. The ideal candidate will have a consistent record of working in technology environment, with a solid focus on Veeva Vault - Clinical Operations. The candidate should be a self-starter and have a strong passion for fostering innovation and excellence in the biotechnology industry. The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. Roles & Responsibilities: Design, Build and maintain integrations between Veeva Vault - Clinical Operations and other applications in the Clinical Operations ecosystem. Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a customer concern point and facilitating communication when service commitments are not met Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle using Scaled Agile Framework (SAFe) Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Contribute and define business outcomes + requirements, technology solutions, and services. Participate in collaborator and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery. Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services. Facilitate standard process sharing, ensuring ongoing alignment with the Technology & Digital strategy. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate Degree OR Master s degree with 4 - 6 years of experience in Business, Engineering, IT or related field OR Bachelor s degree with 6 - 8 years of experience in Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Business, Engineering, IT or related field Preferred Qualifications: Solid experience in implementing and managing application integrations using technologies such as MuleSoft. Experience on Veeva Vault - Clinical Operations applications. Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Experience with version control systems like Git. Good understanding of cloud platforms (e.g., AWS, GCP, Azure) and containerization technologies (e.g., Docker, Kubernetes) Good-to-Have Skills: Extensive experience in the software development lifecycle. Experience with software DevOps CI/CD tools, such Git, Jenkins, Linux, and Shell Script. Experience using and adoption of Scaled Agile Framework (SAFe). Strong analytic/critical-thinking and decision-making abilities. Broad working knowledge of key IS domains and layers. ITIL (preferred) Scaled Agile Framework (SAFe) for Teams Veeva Vault platform (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams What you 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.

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8.0 - 10.0 years

12 - 17 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. We are seeking a seasoned Principal Data Engineer to lead the design, development, and implementation of our data strategy. The ideal candidate possesses a deep understanding of data engineering principles, coupled with strong leadership and problem-solving skills. As a Principal Data Engineer, you will architect and oversee the development of robust data platforms, while mentoring and guiding a team of data engineers. Roles & Responsibilities: Possesses strong rapid prototyping skills and can quickly translate concepts into working code. Provide expert guidance and mentorship to the data engineering team, fostering a culture of innovation and standard methodologies. Design, develop, and implement robust data architectures and platforms to support business objectives. Oversee the development and optimization of data pipelines, and data integration solutions. Establish and maintain data governance policies and standards to ensure data quality, security, and compliance. Architect and manage cloud-based data solutions, using AWS or other preferred platforms. Lead and motivate an impactful data engineering team to deliver exceptional results. Identify, analyze, and resolve complex data-related challenges. Collaborate closely with business collaborators to understand data requirements and translate them into technical solutions. Stay abreast of emerging data technologies and explore opportunities for innovation. 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 8 to 10 years of computer science and engineering preferred, other Engineering field is considered OR Bachelor s degree and 10 to 14 years of computer science and engineering preferred, other Engineering field is considered; Diploma and 14 to 18 years of in computer science and engineering preferred, other Engineering field is considered Demonstrated proficiency in using cloud platforms (AWS, Azure, GCP) for data engineering solutions. Strong understanding of cloud architecture principles and cost optimization strategies. Proficient on experience in Python, PySpark, SQL. Handon experience with bid data ETL performance tuning. Proven ability to lead and develop impactful data engineering teams. Strong problem-solving, analytical, and critical thinking skills to address complex data challenges. Preferred Qualifications: Experienced with data modeling and performance tuning for both OLAP and OLTP databases Experienced with Apache Spark, Apache Airflow Experienced with software engineering best-practices, including but not limited to version control (Git, Subversion, etc.), CI/CD (Jenkins, Maven etc.), automated unit testing, and Dev Ops Experienced with AWS, GCP or Azure cloud services Professional Certifications AWS Certified Data Engineer preferred Databricks Certificate 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.

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4.0 - 6.0 years

8 - 12 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will be responsible for leading and charting the course for the Quality Control technology product team that builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for developing and leading a very hardworking team that is built for delivering high-end and innovative technologies. The ideal candidate will have a proven track record of leadership in technology-driven environments for the Quality Control area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a solid background in end-to-end software development and Quality Control Platforms, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational pivotal initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Maintain strategic relationships and good communication with the leadership team about IS services and service roadmaps to ensure that all the partners feel informed and engaged Lead and manage large, diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle Develop and implement strategic plans for technology and workforce. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Attract and recruit top talent as part of an extensive Technology organization to be hired within India. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Responsible for managing, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Understand the decision-making process, workflows, and business and information needs of business partners and stakeholders Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a partner concern point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Facilitate standard methodology sharing, ensuring ongoing alignment with the Technology & Digital strategy Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy What we expect of you We are all different, yet we all use our unique contributions to serve patients. The vital attribute in a professional we seek with these qualifications Basic Qualifications: Master s degree with 4 - 6 years of experience in Business, Engineering, IT or related field OR Bachelor s degree with 6 - 8 years of experience in Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Business, Engineering, IT or related field Preferred Qualifications: Must-Have Skills Demonstrated experience in handling technology initiatives and teams with a track record of successful innovation Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Must be flexible and able to handle multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Exceptional collaboration, communication and interpersonal skills to effectively handle collaborator relationships and build new partnerships. Experience in applying technology standard process methodologies: Scaled Agile (SAFe), ITIL, etc. GMP and Validation Experience on Pharmaceutical / Regulated Industry Experience with Managing Quality Control Platforms on a Global Enterprise Environment Have good eye for business. Can demonstrate deep understanding of industry, therapy and product Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Knowledge on Investigational Methodologies and Technical Writing Proficiency Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and fix skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams 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.

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6.0 - 8.0 years

8 - 12 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital The Master Data Product Manager will be responsible for coordinating and driving complex SAP data structure setup activities to ensure data integrity, accuracy, timeliness, and compliance across Amgen s operations. This role focuses on strategically optimizing and maintaining key processes, handling complex governance issues, and managing team members. The Product Manager will collaborate with cross-functional teams to align data structure management practices with business objectives. The role requires strategic thought leadership in enabling business processes, acumen of information flow across multiple systems, and managerial skills to govern the data structure setup process. Roles & Responsibilities: Maintain documentation and serve as the SME on data structure definitions, data flows, access rights models, etc. Manage, maintain, and optimize business processes, ensuring the accuracy, consistency, and governance of SAP data structure setup Sheperd projects, ensuring seamless data flow between systems and platforms. Collaborate with IT and business teams to identify and resolve complex data structure governance issues and operational challenges Collaborate with cross-functional partners to work on business processes such as change control, deviation support, and troubleshooting process issues Monitor and analyze success of structure setup criteria, implementing continuous improvements to enhance operational efficiency Ensure compliance with governance policies and industry regulations What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications and Experience: Bachelor s degree in a STEM discipline and 6-8 years of experience in SAP ECC, master data management, data/process governance, or data operations in a biotech manufacturing context Master data knowledge in domains such as Material Master, Production Master, and Plant Experience leading data-oriented projects across large-scale operations Strong analytical and problem-solving skills with a focus on data accuracy and process optimization Functional Skills: Must-Have Skills: Displays both a business and technical understanding of SAP ERP, understanding the implications of decisions Proven experience working on cross-functional process governance with a data orientation Proficient in demonstrating MS Office, project management tools, and visualization tools to track and manage tasks, dependencies, risks, etc. Strong ability to coordinate, manage, and drive initiatives while ensuring compliance with regulations Excellent problem-solving and analytical skills with a focus on optimizing processes and aligning business activities Experience managing complex projects involving SAP Strong cross-functional collaboration skills, with the ability to communicate technical concepts to non-technical partners Good-to-Have Skills: SAP S/4, SAP MDG, MES 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 with ownership of results. 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 look after 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.

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1.0 - 3.0 years

2 - 5 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. The primary responsibility of this role is to perform quality control reviews of of Amgen s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. 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 pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e.g., PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e.g., Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts. Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience Including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelor s / Master s degree in Health/Life Sciences with minimum 2 - 3 years of Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports. 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.

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3.0 - 8.0 years

3 - 5 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will be part of the Global Patient Safety organization this team implements Intake and Triage of product complaints (PCs), adverse events (AEs) and other safety findings (OSFs). Their focus includes assuring compliant processes and systems remain fully compliant through the pharmacovigilance and quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Job Summary The PC Triage and Intake Associate is responsible for global triage of Product Complaints and ensure proper Adverse Events and/or Other Safety Findings were captured. Ensure to capture the patient outcome because of the reported event. This position ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes, and procedures. Key Activities Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete. Performs the initial book-in activities and appends additional information or documents to the case as they are received in the global intake system. Ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes and procedures. Supports performance emphasized culture. Ensures quality of PC, AE and OSF records. Implements Standard Operating Procedure requirements for the triage process. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Education & Experience (Basic) Master s degree and 3 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 5 years of Drug Safety or Life Sciences experience Education & Experience (Preferred) Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry Bachelor s Degree in a health-care subject area or scientific field Previous experience with a corporate intake system or safety database Ability to successfully manage workload to strict timelines Familiarity with basic project management tools Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices) 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.

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