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12.0 - 17.0 years

13 - 17 Lacs

Hyderabad

Work from Office

The Senior Manager - Technology, will lead and coordinate cross-functional technology teams with a focus on Omics and Multi-Omics product development to enable target and biomarker discovery. This role combines strategic leadership, product ownership, and operational oversight, with a strong emphasis on global collaboration. This hands-on leader is primarily responsible for maximizing the value delivered by the team by ensuring that the team backlog is aligned with end-user and stakeholders needs across R&D. This role involves close collaboration with Architecture and Engineering leads supporting product teams along with scientific community representative stakeholders across R&D to define and prioritize features and provide a roadmap for feature development. The ideal candidate has strong experience in product management, specifically related to products that deliver Omics data technologies that enable scientists to perform high throughput analytics to elucidate disease biology, mechanism of action and pathway analysis. The role requires exceptional communication skills, and a deep understanding of Agile methodologies. Roles & Responsibilities: Manage and mentor junior technology staff across product teams, fostering a culture of innovation, accountability, continuous improvement and a sense of belonging. Collaborate and align with global product owners to ensure product teams are committed and focused on delivering on SAFe PI objectives for the business 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 stakeholder groups Create, prioritize, and maintain the feature backlog, ensuring that it reflects the needs of the business and stakeholders Collaborate with stakeholders to gather and document product requirements, user stories, and acceptance criteria Work closely with the business teams, Scrum Master and development team to plan and execute sprints, ensuring that the highest priority features are delivered Identify opportunities to improve the product / platform / system and development process, and make data-driven decisions to enhance the product / platform Oversee the day-to-day management of technology platforms, ensuring that they meet performance, security, and availability requirements Manage relationships with product / platform /system vendors, ensuring that service levels are met and that the organization derives the best value from its investments Ensure that platforms comply with security standards, regulatory requirements, and organizational policies Oversee the management and operation of specific IT systems, ensuring that they meet performance, security, and availability requirements Manage product team Architects, Analysts and Validation Engineers and provide role-based standards and career mentorship for these roles Assure that the team is successfully creating robust written materials, including product documentation, product backlog and user stories, and creating other need artifacts to assure efficient and effective coordination across time zones. Analyze product performance data, customer behavior, and market trends to inform product decisions Create and maintain reports and dashboards that provide insights into product performance, user engagement, and other key metrics Conduct market research and competitive analysis to identify opportunities and inform product strategy Analyze customer feedback and support data to identify pain points and opportunities for product improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications and Experience: Doctorate degree / Masters degree / Bachelors degree and 12 to 17 years of experience in Life Sciences, Computer Science, IT, Computational Biology/Bioinformatics or related field. Must-Have Skills: Strong knowledge of Agile methodologies (SAFe) and product management principles, and backlog and feature management tools including Jira and Confluence Strong knowledge of IT service management (ITSM) principles and methodologies Extensive experience in leading teams, mentoring junior professionals, and cultivating the next generation of talent Strong communication and organizational abilities with a proven capacity to manage multiple priorities effectively. Proven record of implementing technology solutions in a large organization Good-to-Have Skills: Good Knowledge of the Global Pharmaceutical Industry Understanding of GxP process Strong solution design and problem-solving skills Strong understanding of technology, function, or platform Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Working late hours Professional Certifications: Experience with current cloud technologies (AWS, Azure etc.), use of AI and large language models (LLMs), programming languages (Python, R) Experience working in biopharma R&D with emphasis on implementing research technologies Knowledge of GxP system validation processes Soft Skills: Excellent analytical and troubleshooting skills Highest degree of initiative and self-motivation Strong verbal and written communication skills, including presentation of varied audiences through complex technical/business topics Confidence in leading teams through prioritization and sequencing discussions, including managing stakeholder expectations Ability to work effectively with global, virtual teams, leveraging tools and artifacts available to assure clear and efficient collaboration across time zones Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong problem solving, analytical skills Ability to learn quickly and retain and synthesize complex information from diverse 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. Equal opportunity statement

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14.0 - 19.0 years

10 - 14 Lacs

Hyderabad

Work from Office

We are seeking a Talent Intelligence Lead ( Senior Manager ) to build and lead Amgen s newly established Global Talent Intelligence function. This strategic role sits within our Global Talent Acquisition team and will be central to shaping how Amgen uses data, technology, and insights to anticipate future workforce needs, proactively map markets, and enable executive and strategic hiring across regions. You will be responsible for launching and managing a team that connects real-time labor market insights, predictive analytics, and global talent mapping to key executive and business priorities in full alignment with the strategic direction enterprise leadership . This position will work closely with leaders across HR, Executive Search, and Workforce Planning to build a best-in-class capability, leveraging platforms such as Workday, Eightfold CRM, LinkedIn Talent Insights, and other leading intelligence tools. Key Responsibilities Include: Talent Intelligence Strategy : Build and lead a scalable global talent intelligence capability, enabling strategic hiring decisions with data-driven insights, trends, and forecasts. Executive Talent Mapping : Develop frameworks to proactively identify and track key executive talent across biotech, life sciences, and pharma industries in alignment with strategic priorities. Global Market Insights : Deliver deep labor market analyses and benchmarking reports to inform location strategies, skills availability, and hiring feasibility. Pipeline Development : Collaborate with Strategic Sourcing to inform proactive pipelines and candidate nurturing strategies across critical job families and executive roles. CRM & Talent Data Infrastructure : Partner with TA Tech and Platforms to build tagging structures and segmentation strategies that enable scalable and actionable CRM engagement. Stakeholder Partnership : Serve as a trusted advisor to Talent Acquisition, HR Business Partners, and senior leadership by translating complex talent data into clear, actionable recommendations. Innovation & Enablement : Champion the adoption of new technologies , tools, and intelligence platforms to maximize efficiency and impact. Capability Building : Lead and mentor a high-performing team of talent intelligence professionals; foster a culture of curiosity, continuous learning, and operational excellence. What we expect from you Bachelor s degree in Business, Human Resources, Data Analytics, or related field. Total professional experience of at least 14 years, demonstrating a strong foundation across Human Resources or related domains. Minimum of 7 years of progressive experience in Talent Intelligence, Strategic Sourcing, Executive Search, or Talent Strategy, preferably in a large, global organization. Experience launching or scaling a talent research or labor market insights function with direct impact on strategic hiring. Familiarity with tools such as Workday, innovative CRM technologies, LinkedIn Talent Insights, TalentNeuron , or equivalent market intelligence platforms. Strong analytical mindset with the ability to convert data into meaningful stories, dashboards, and strategic outcomes. Experience with CRM segmentation, candidate lifecycle marketing, and passive talent engagement strategies. Demonstrated ability to influence and consult across senior levels of the organization. Excellent communication, project leadership, and change management skills. Proven experience managing and mentoring a small team or building new capabilities from the ground up. Thrive What you can expect from us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. We offer competitive annual base salary, and a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. .

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8.0 - 10.0 years

7 - 11 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will lead an Agile product squad and responsible for defining the vision & strategy and implementation for a range of Clinical Data products supporting Amgen Clinical Trial Design & Analytics. You will collaborate closely with statisticians, data scientists, data engineers, and AI/ ML engineers teams to understand business needs, identify system enhancements, and drive system implementation projects. Your extensive experience in business analysis, system design, and project management will enable you to deliver innovative and effective technology products. Roles & Responsibilities: 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 Create, prioritize, and maintain the feature backlog, ensuring that it reflects the needs of the business and collaborators Collaborate with collaborators to gather and document product requirements, user stories, and acceptance criteria Work closely with the business teams, Scrum Master and development team to plan and implement sprints, ensuring that the highest priority features are delivered Oversee the day-to-day management of technology platforms, ensuring that they meet performance, security, and availability requirements Ensure that platforms comply with security standards, regulatory requirements, and organizational policies Assure that AIN team is successfully creating robust written materials, including product documentation, product backlog and user stories, and creating other need artifacts to assure efficient and effective coordination across time zones. Oversee the resolution of service-related incidents and problems, ensuring minimal impact on business operations Maintains in-depth knowledge of clinical development business domains with an emphasis in data assets and data pipelines, as well as an understanding of the multi-functional dependencies. Analyze customer feedback and support data to identify pain points and opportunities for product 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 8 to 10 years of Information Systems experience OR Bachelor s degree and 10 to 14 years of Information Systems experience OR Diploma and 14 to 18 years of Information Systems experience A solid foundation in modern software design and engineering practices and business analysis. Proven experience in undemanding and gather business requirements and delivered insight, and achieved concrete business outcome. Technical Proficiency: Good understanding of the following technologies: Python, R, AI/ML frameworks, relational databases/data modeling, AWS services ( EC2, S3, Lambda, ECS, IAM), Docker and CI/CD/Gitlab, Apache/Databricks, Expert understanding and experience of clinical development process within Life Sciences (global clinical trial data sources, SDTM & AdaM, end-to-end clinical data design and analysis pipeline, clinical data security and governance) Experience in Agile product development as a participating member of a scrum team and related ceremonies and processes Ability to collaborate with data scientists and data engineers to deliver functional business requirements as well defining product roadmap. High learning agility, demonstrated ability of quickly grasp ever changing technology and clinical development domain knowledge and applied to the project work. Strong communications skills in writing, speaking, presenting and time management skills. Preferred Qualifications: Training or education degree in Computer Science, Biology, or Chemistry. Experience with Clinical Data and CDISC (SDTM and ADaM) standard Soft Skills: Excellent analytical and troubleshooting skills Deep intellectual curiosity, particularly about data patterns, and learning about business processes and life of the user Highest degree of initiative and self-motivation Strong verbal and written communication skills, including presentation of varied audiences through complex technical/business topics Confidence in leading teams through prioritization and sequencing discussions, including managing collaborator expectations Ability to work effectively with global, virtual teams, specifically including leveraging of tools and artifacts to assure clear and efficient collaboration across time zones Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong problem solving, analytical skills; Ability to learn quickly and retain and synthesize complex information from diverse 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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2.0 - 7.0 years

10 - 14 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role as Senior Manager Information Systems, you will lead a dynamic team of technical product owner, data engineers, AI & software engineers, business analysts, test/validation engineers and scrum master to deliver cutting edge innovative GEN AI solutions across various Process development functions(Drug Substance, Drug Product, Attribute Sciences & Combination Products) in Operations area . The role involves developing and implementing cutting edge GEN AI solutions and strategies, collaborating with cross-functional teams, and ensuring the scalability, reliability, and performance of AI solutions adhering to Amgen Enterprise AI strategy and roadmap. You will also be the reporting manager for this team and will be responsible for the coaching and development of these resources. The team will rely on your leadership to own and refine the vision, feature prioritization, partner alignment, and experience leading solution delivery while building this ground-breaking new capability for Amgen The ideal candidate will have a consistent track record of leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. This role requires deep expertise in handling the end-to-end development and delivery of customer-facing digital product capabilities and platforms leverage generative AI based digital solutions. They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. 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, technical product ownership, business analysis, and be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Maintain strategic relationships and strong communication with the leadership team to ensure all collaborators feel informed and engaged Oversee the software development lifecycle, ensuring standard methodologies in development, testing, and deployment across the product teams Lead and handle large teams with varied strengths within a matrixed organization, collaborating with geographically dispersed teams, including those in the US and international locations Develop and implement strategic roadmaps and plans for technology and workforce growth, including recruiting top talent and building a robust team in India Developing talent, motivating the team, delegating effectively, championing diversity within the team, and acting as a role model of servant leadership Ensuring global ways of working are embedded in the local organization Develop a culture of collaboration, innovation, and continuous improvement, driving talent development, motivation, and effective delegation Fostering standard methodology sharing and alignment with business goals Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet Participate in team member and leadership meetings, working with other parts of the organization and functional groups to ensure successful delivery and alignment with strategy, compliance, and regulatory requirements Remain accountable for ensuring overall organizational security and compliance with quality and GxP in technology services Monitor emerging AI tools and technologies and trends to find opportunities for platform growth and expansion 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: Doctorate Degree and 2 years of experience in Engineering, IT or related field OR Master s degree with 8 - 10 years of experience in Engineering, IT or related field OR Bachelor s degree with 10 - 14 years of experience in Engineering, IT or related field OR Diploma with 14 - 18 years of experience in Engineering, IT or related field Background as a Technical Product Owner (TPO), people manager, and business analyst, ensuring the ability to oversee and guide a team to translate business needs into definition and delivery of technical solutions, guiding development teams, prioritizing features, and ultimate delivery and management of the digital products. Proven leadership skills with the ability to lead large matrixed teams, demonstrated experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements. Experience in implementing innovative web applications, Data Engineering and integration, Enterprise data fabric concepts, methodologies, and technologies e.g. React js, Python, Django, Fast API, AWS technologies, Databricks, DevOps CI/CD Experience in implementing innovative scalable GEN AI solutions using Retrieval-augmented generation (RAG), AI Agents, Vector stores, AI/ML platforms, embedding models e.g Open AI, Langchain, Redis, pgvector. Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology. Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Degree in Computer Science, Information Systems, Engineering, or Life Sciences. Preferred Qualifications: At least 5 - 8 years of domain knowledge in health and/or life sciences combined with Information Technology Understanding, and preferably applied experience and knowledge, in data management and CTD document drafting Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation. Experience driving a collaborative culture that values technical depth, accountability, and customer service. Strong problem-solving and analytical skills. Demonstrated ability to work effectively in a fast-paced, dynamic environment. Understanding of ITIL processes and implementation. Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products. 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 Work Hours: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

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10.0 - 12.0 years

10 - 14 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role as Senior Manager Information Systems, you will lead a dynamic team of technical product owners, business analysts, developers, test/validation engineers, project managers and scrum masters responsible for the ongoing design, development, management, and optimization of Amgen s digital products enabling the regulatory submission content automation initiative. You will also be the reporting manager for this team and will be responsible for the coaching and development of these resources. The ideal candidate will have a consistent track record of leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. The role requires deep expertise in handling the end-to-end development and delivery of customer-facing digital product capabilities and platforms including generative AI, structured content management. They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. 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, technical product ownership, business analysis, be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Maintain strategic relationships and strong communication with the leadership team to ensure all collaborators feel informed and engaged Oversee the software development lifecycle, ensuring standard methodologies in development, testing, and deployment across the product teams Lead and handle large, teams with varied strengths within a matrixed organization, collaborating with geographically dispersed teams, including those in the US and international locations Develop and implement strategic plans for technology and workforce growth, including recruiting top talent and building a robust team in India Developing talent, motivating the team, delegating effectively, championing diversity within the team, and acting as a role model of servant leadership Ensuring global ways of working are embedded in the local organization Develop a culture of collaboration, innovation, and continuous improvement, driving talent development, motivation, and effective delegation Fostering standard methodology sharing and alignment with business goals Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet Participate in team member and leadership meetings, working with other parts of the organization and functional groups to ensure successful delivery and alignment with strategy, compliance, and regulatory requirements Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion 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 10 - 12 years of experience in Engineering, IT or related field OR Bachelor s degree with 12 - 14 years of experience in Engineering, IT or related field Background as a Technical Product Owner (TPO), people manager, and business analyst, ensuring the ability to oversee and guide a team to translate business needs into definition and delivery of technical solutions, guiding development teams, prioritizing features, and ultimate delivery and management of the digital products. Proven experience working with large-scale data environments comprising data pipelines, and enterprise cloud solutions. In-depth knowledge of data engineering concepts, ETL processes, and data architecture principles. Strong understanding of cloud computing principles, particularly within the AWS ecosystem Working knowledge of 21 CFR, ISO 13485 and experience working in regulatory environments Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrated experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements. Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology. Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Degree in Computer Science, Information Systems, Engineering, or Life Sciences. Preferred Qualifications: At least 5 - 8 years of domain knowledge in health and/or life sciences combined with Information Technology Proficiency in Python/PySpark development, Fast API, PostgreSQL, Databricks, DevOps Tools, CI/CD, GitLab, and Data Ingestion. Understanding, and preferably applied experience and knowledge, in data management and CTD document drafting Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation. Experience driving a collaborative culture that values technical depth, accountability, and customer service. Strong problem-solving and analytical skills. Demonstrated ability to work effectively in a fast-paced, dynamic environment. Understanding of ITIL processes and implementation. Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products. 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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5.0 - 9.0 years

8 - 12 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will be member of the technical team that develops and implements technology strategies, solutions, and services to support Amgen s Global Medical business function. As the Software Engineer, you will be the primary accountable for developing integration of several capabilities and the point of contact for the business & technology product owner and other stakeholders on integration pipelines. This role will work closely with business and technology teams to efficiently build, develop, deploy, scale, and operate technology solutions and software products and be responsible for development and lifecycle management of integration pipelines. The Senior Associate will be a responsible member of a high-performing Agile Product Team consisting of business analysts, software engineers, solution architects, system configurators, etc. Roles & Responsibilities: Be an accountable member on the identified agile product team and portfolio of software applications Enable the technology ecosystem for Global Medical Data and Analytics platform team and ensure that the platforms meet their business needs and enterprise technology standards Implement a robust DevOps pipeline for the product using Amgen s CI/CD frameworks and tools Development to deployment of data integration User Stories, Data pipelines and APIs using city planning technology using tools like databricks, MuleSoft, AWS, salesforce connectors, Python, GIT Support Lifecycle management and ownership of technology assets. Develop cross-functional collaborations with platform teams to maintain enterprise standards Drive a Product First attitude amongst the team and peers with a goal towards global expansion of the product s capabilities Drive an attitude of excellence in running robust, reliable, and secure software products following Amgen s software development, operating procedures, and change management requirements Unblock and drive engagement to improve results delivery for the team and the organization Drive external software product and service partners to deliver excellence Develop and mentor the team of engineers, architects, and data scientists for higher performance, and individual career growth. Act as a role model demonstrating leadership behaviors Partner with leadership in the Global Medical organization to define, develop, and implement technology solutions aligned with the organization s goals and objectives, with a focus on increasing the effectiveness of the organization. Establish and maintain successful relationships with internal DTI platform and shared services product teams, strategic external partners, industry bodies, to learn, influence, and attract the best talent. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Masters degree / Bachelors degree and 5 to 9 years of Information Systems experience. Preferred Qualifications: Functional Skills 5+ years of IT Industry work experience in analysis, design, development, testing and maintenance of software applications in the Health & Life Sciences industry 2+ years of experience supporting Medical Affairs business teams Experience working on major programs/projects that involve multiple partners and external vendors Experience in lifecycle management of technology applications and data pipelines Experience working in Scaled Agile Framework (SAFe), especially in regulated setting including ability to lead the transformation of teams from a service based to a product-based model Working experience on Enterprise Datalake(EDL) and technologies like Databricks, AWS, Mulesoft, SQL, Spark, Python, API, REACT framework, GITLab, MLOps etc. In-depth experience in all aspects of SDLC from requirements, design, testing, data analysis and Change Control process combined with experience developing project charters, statement of work and project financials Experience with data warehousing and EDL technologies like databricks to build integrations across multiple systems An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Experience or working knowledge of SaaS solutions like Salesforce, Veeva, AWS, etc. Experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for data integrity, security, and audit readiness. Experience driving a collaborative culture that values technical depth, accountability, and customer service. Strong problem-solving and analytical skills. Demonstrated ability to work effectively in a fast-paced, dynamic environment. Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of the ServiceNow platform Professional Certifications Preferred certification in SAFe for Teams Preferred certification in EDL tools like databricks Preferred AWS certifications Soft Skills: Excellent leadership skills with the ability to work in collaborative teams and cultivate talent. Demonstrated ability to influence decisions with business & technology collaborators & leadership Data-driven decision making Excellent verbal and written communication skills for technical and non-technical audiences of various levels in the organization. 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 Excellent analytical and troubleshooting skills Ability to work effectively with global, virtual teams Equal opportunity statement We will ensure that individuals with disabilities are provided with 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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3.0 - 8.0 years

30 - 35 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. Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates and structured data formats for consistent and compliant submissions. Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases. Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards. Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations. Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms. Participate in training activities to expand internal capabilities in digital tools and regulatory data automation. Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards. Basic Qualifications: Doctorate degree OR Master s degree and 3 years of directly related experience OR Bachelor s degree and 5 years of directly related experience Experience managing and leading a team in a regulatory or compliance environment Preferred Qualifications: Degree in life sciences, digital or data science, biochemistry, or chemistry Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements Background or basic experience in digitalization, automation, software development Background in manufacturing, process development, quality control, or quality assurance Hands-on experience with Veeva Vault platforms and regulatory technology solutions. What we expect from you We are all different, yet we all use our unique contributions to serve patients. 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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12.0 - 14.0 years

30 - 35 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. We are seeking a Associate Director of ML / AI Engineering to lead Amgen India s AI engineering practice. This role is integral to developing top-tier talent, setting ML / AI best practices, and evangelizing ML / AI Engineering capabilities across the organization. The Associate Director will be responsible for driving the successful delivery of strategic business initiatives by overseeing the technical architecture, managing talent, and establishing a culture of excellence in ML / AI The key aspects of this role involve : (1) prior hands-on experience building ML and AI solutions (2) management experience in leading ML / AI engineering team and talent development (3) Delivering AI initiatives at enterprise scale Roles & Responsibilities: Talent Growth & People Leadership: Lead, mentor, and manage a high-performing team of engineers, fostering an environment that encourages learning, collaboration, and innovation. Focus on nurturing future leaders and providing growth opportunities through coaching, training, and mentorship. Recruitment & Team Expansion: Develop a comprehensive talent strategy that includes recruitment, retention, onboarding, and career development and build a diverse and inclusive team that drives innovation, aligns with Amgens culture and values, and delivers business priorities Organizational Leadership: Work closely with senior leaders within the function and across the Amgen India site to align engineering goals with broader organizational objectives and demonstrate leadership by contributing to strategic discussions Create and implement a strategy for expanding the AI/ML engineering team, including recruitment, onboarding, and talent development. Oversee the end-to-end lifecycle of AI/ML projects, from concept and design through to deployment and optimization, ensuring timely and successful delivery. Ensure adoption of ML-Ops best practices, including model versioning, testing, deployment, and monitoring. Collaborate with multi-functional teams, including product, data science, and software engineering, to find opportunities and deliver AI/ML solutions that drive business value. Serve as an AI/ML evangelist across the organization, promoting awareness and understanding of the capabilities and value of AI/ML technologies. Promote a culture of innovation and continuous learning within the team, encouraging the exploration of new tools, technologies, and methodologies. Provide technical leadership and mentorship, guiding engineers in implementing scalable and robust AI/ML systems. Work closely with collaborators to prioritize AI/ML projects and ensure timely delivery of key initiatives. Lead innovation initiatives to explore new AI/ML technologies, platforms, and tools that can drive further advancements in the organization s AI capabilities. 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 12 to 14 years of computer science, Artificial Intelligence, Machine Learning experience OR Bachelor s degree and 14 to 18 years of computer science, Artificial Intelligence, Machine Learning experience OR Diploma and 18 to 20 years of computer science, Artificial Intelligence, Machine Learning experience Preferred Qualifications: Experience in building AI Platforms & applications at enterprise scale Expertise in AI/ML frameworks and libraries such as TensorFlow, PyTorch, Scikit-learn, etc. Hands-on experience with LLMs, Generative AI, and NLP (e.g., GPT, BERT, Llama, Claude, Mistral AI ) Strong understanding of MLOps processes and tools such as MLflow, Kubeflow, or similar platforms. Proficient in programming languages such as Python, R, or Scala. Experience deploying AI/ML models in cloud environments (AWS, Azure, or Google Cloud). Proven track record of managing and delivering AI/ML projects at scale. Excellent project management skills, with the ability to lead multi-functional teams and manage multiple priorities. Experience in regulated industries, preferably life sciences and pharma Good-to-Have Skills: Experience with natural language processing, computer vision, or reinforcement learning. Knowledge of data governance, privacy regulations, and ethical AI considerations. Experience with cloud-native AI/ML services (Databricks, AWS, Azure ML, Google AI Platforms) Experience with AI Observability Professional Certifications (Preferred): Google Professional Machine Learning Engineer, AWS Certified Machine Learning, or Azure AI Engineer Associate, Databricks Certified Generative AI Engineer Associate Soft Skills: Excellent leadership and communication skills, with the ability to convey complex technical concepts to non-technical collaborators. Ability to foster a collaborative and innovative work environment. Strong problem-solving abilities and attention to detail. High degree of initiative and self-motivation. Ability to mentor and develop team members, promoting their growth and success. 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

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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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1.0 - 3.0 years

1 - 5 Lacs

Hyderabad

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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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4.0 - 6.0 years

8 - 12 Lacs

Hyderabad

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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

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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

7 - 11 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital 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 pivotal 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 Conduct market research, new platform and technology evaluations 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: MS or PhD in Bioinformatics, Computational Biology, Computational Chemistry, Life Sciences, Computer Science or Engineering 5+ years of experience in designing and supporting biopharma scientific research data analytics Functional Skills: Must-Have Skills (Not more than 3 to 4): Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with data Understanding of semantics and FAIR (Findability, Accessibility Interoperability and Reuse) data concepts Understanding of knowledge graphs, taxonomy and ontology concepts in life sciences and chemistry domains 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. Good-to-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific data strategy, data governance, data infrastructure 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 Familiarity with data analytics and scientific computing platforms such as Databricks, Dash, Plotly, Spotfire and related programming languages like SQL, python 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 (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) Certified 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.

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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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7.0 - 8.0 years

13 - 17 Lacs

Hyderabad

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Let s do this. Let s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Manager include: Support the new hire onboarding program Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness Drive consistency across Global CMC & Device Regulatory Affairs Develop and maintain training materials Global CMC & Device Regulatory Affairs Train staff on select departmental processes and procedures Ensure consistent use of processes and tools across department Continuous improvement of templates for presentations, timelines, trackers, and other tools Liaise with functions in GRAAS and Operations to ensure alignment Participate in cross-functional special project teams Potential to oversee or manage staff What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master s/ Doctorates degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor s degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Technical & Functional Expertise: Bachelor s degree or higher in Life Sciences, Engineering, or a related field Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry Working knowledge of Regulatory CMC processes and global submission requirements Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms) Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus Collaboration & Communication Skills: Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal communication skills, with experience presenting to diverse audiences Demonstrated ability to collaborate across global, cross-functional, or matrixed teams Experience supporting onboarding, training, or continuous improvement initiatives Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency 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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1.0 - 3.0 years

2 - 5 Lacs

Hyderabad

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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

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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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2.0 - 7.0 years

4 - 9 Lacs

Hyderabad

Work from Office

Lets do this. Lets change the world. In this vital role you will be reporting to the Senior Manager, Corporate Learning Programs, where the Manager will serve as a learning professional and client interface for all corporate functions (HR, Law, etc.) In that capacity, the Manager is responsible for: Work closely with our annual processes and platform to connect learning solutions and programs with Amgen s individual- and manager-effectiveness priorities Understanding our corporate clients business drivers and working with them to define and execute long-range performance strategies Partnering with the client on needs analyses that provide a comprehensive look at performance opportunities and barriers and that define the scope and deliverables of specific training solutions Shepherding those specific learning projects through the governance and intake process Acting as a design consultant while supporting both the client and Amgens internal training development team during the life of a training solution project Working alongside fellow team members to define and enhance the instructional and interactive strategies of our core enterprise development products: Learning for Growth and Amplifying Manager Performance Collaborating with Global Learning Solutions and Amgens IS/IT team to help define a technology roadmap for enterprise learning The Manager will be the liaison between our Talent team and Amgens internal learning development and technology team. In that role, the Manager will work with Amgens Global Learning Solutions Team to help define the learning ecosystem and technology infrastructure. The Manager will need to be versed in learning platforms and tools, digital strategy and marketing, and in current trends in the broader learning space. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Corporate Learning Programs Manager professional we seek will have these qualifications. Basic Qualifications: Doctorate degree OR Masters degree and 2 years of Talent, Learning and Development, or Instructional Design experience Or Bachelors degree and 4 years of Talent, Learning and Development, or Instructional Design experience Or Associates degree and 10 years of Talent, Learning and Development, or Instructional Design experience Or High school diploma / GED and 12 years of Talent, Learning and Development, or Instructional Design experience Preferred Qualifications: Experience in instructional design, human performance technology, learning systems & platforms, life sciences, or business Experience with performance consulting and needs analysis eLearning design experience and a broad knowledge of learning technology, learning experience platforms, internal talent marketplaces, and other virtual platforms Experience using Agile or other design and development methodologies in the creation of learning solutions Experience in project management (managing projects, defining scope, overseeing budget, tracking milestones) Effective communication and writing skills Ability to work with staff across multiple levels of an organization Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible

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5.0 - 10.0 years

12 - 16 Lacs

Hyderabad

Work from Office

The Global Mobility Manager is responsible for developing, managing, and executing relocation and immigration strategies that support the international talent mobility needs of a rapidly growing biotech company. This role ensures compliance with immigration laws and regulations, delivers a seamless relocation experience, and supports talent acquisition and retention efforts across multiple countries. Key Responsibilities Include: Immigration Management Oversee all global immigration processes, including work permits, visas, green cards, and permanent residency for employees and their families. Partner with external immigration counsel to ensure timely and compliant case management. Monitor changes in global immigration laws and proactively adjust company policies and practices. Serve as a subject matter expert to HR, legal, and business units on immigration strategies and risk. Relocation Program Oversight Design and manage domestic and international relocation programs for new hires, transfers, and expatriates. Coordinate logistics with third-party relocation vendors (e.g., household goods shipping, temporary housing, travel). Manage policy exceptions and escalations with empathy and alignment to business needs. Ensure positive relocation experiences to enhance employee engagement and retention. Stakeholder Collaboration Work closely with HR Business Partners, Talent Acquisition, Legal, Tax, Payroll, and Finance teams to support global mobility initiatives. Advise hiring managers and leadership on global talent movement and cost-effective mobility solutions. Deliver training and support for HR and line managers on relocation and immigration best practices. Compliance & Reporting Maintain compliance with all global mobility regulations, including tax, social security, and employment laws. Ensure accurate and secure recordkeeping for audits and data protection. Generate and analyze reports on immigration metrics, vendor performance, and employee satisfaction. Vendor & Budget Management Manage relationships and contracts with immigration law firms and relocation vendors. Monitor program costs and manage mobility budgets in partnership with Finance. Evaluate vendor performance and recommend process improvements. Win What we expect from you. Bachelors degree in Human Resources, International Business, Law, or related field; advanced degree or certifications (e.g., GMS, SHRM) preferred. 5+ years of experience in global mobility and immigration, preferably in the biotech, pharmaceutical, or life sciences industry. Strong knowledge of U.S. and global immigration regulations (e.g., H-1B, L-1, O-1, EU Blue Card, intra-company transfers). Experience managing global relocation programs and working with relocation vendors. Exceptional interpersonal and communication skills with the ability to influence stakeholders at all levels. Proven project management and problem-solving skills in a fast-paced, complex environment. High attention to detail and commitment to confidentiality and compliance. Experience supporting scientists, researchers, and other specialized roles with niche visa requirements. Familiarity with mobility tax issues and coordination with tax advisors. Knowledge of biotech industry-specific challenges in global workforce deployment. Results-oriented mindset with a focus on driving outcomes and delivering exceptional results. Thrive What you can expect from us. As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. We offer competitive annual base salary, and a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. .

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8.0 - 13.0 years

3 - 7 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will be responsible for the recruitment strategy and efforts for Amgen India as well as other positions across Amgen as needed, his position will also play a key role in developing and delivering best-in-class recruitment services to ensure Amgen is positioned to attract and recruit exceptional talent. Create and implement sourcing strategies to source the best leadership talent. Exercise a wide degree of creativity, near- and long-term sourcing vision, business understanding, and personal organization. Create and maintain healthy talent pipeline for steady flow of qualified candidates Review resumes and credentials for appropriateness of skills, experience and knowledge in relation to position requirements. Build and maintain strong working relationships with Hiring Managers, functional leaders, and other HR team members to build a partnership that yields success, predictable results and credibility. Prepare candidates for interviews and specific hiring managers by providing detailed information on the company, our mission, company culture, department background, job descriptions, and expectation-setting. Stay informed of trends and innovative sourcing/recruiting techniques to be driven in innovative recruiting practices. As a brand ambassador, develop and deliver Amgens message of opportunity, success, diversity and potential to candidates and prospects. Provide regular updates to HR leadership on recruitment progress and updates. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of Recruiting or Sourcing experience Preferred Qualifications: Must Have Previous sourcing experience at the professional and management team level. Experience delivering results by creating, implementing and driving an executive or functional recruitment processes while exhibiting subject matter expertise to influence executives and other business leaders or decision makers. Knowledge of Client Relationship Manager (CRM) tools such as Eightfold, Applicant Tracking Systems (ATS) such as Workday, LinkedIn Recruiter, Microsoft Office Suite and AI sourcing technologies Good to Have Life-sciences (Biotech/Pharmaceutical) industry experience Strategic adviser that drives excellence and takes accountability of recruitment processes and results to ensure outstanding experience for candidates and hiring managers. Soft Skills: Leadership and relationship-building skills with executives, senior leaders, various cross-functional partners, HR (business partners, compensation/benefits, mobility) and executive support staff. Exercise discretion and sound judgement, uses analytical approach and has ability to think proactively and strategically throughout the recruitment and negotiation process Communication and executive level presentation skills with the ability to express ideas in a persuasive, confident, organized and eloquent manner 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 - 12.0 years

7 - 12 Lacs

Hyderabad

Work from Office

The External Workforce Sr. Manager is responsible for supporting the management and coordination of the organizations external workforce in partnership with our Master Service Providers (MSP), including contingent workers, independent contractors, vendors, and service providers. This role will lead the planning, governance, and operational management of our external workforce to ensure the efficient use of labor categories and other external resources across the organization while maintaining compliance, optimizing cost, and enhancing workforce agility. This role works cross-functionally with HR, Procurement, Legal, IT, and department heads to ensure cost-effective and compliant use of external talent. As a critical member of our external workforce team, you will help ensure the organization can scale flexibly and compliantly, while meeting the specialized talent needs of a fast-paced and regulated biotech environment. Key Responsibilities: Strategy & Governance Develop and implement an enterprise-wide external workforce strategy aligned with scientific, clinical, and operational goals. Establish and maintain governance frameworks, policies, and compliance standards in partnership with Legal, HR, Procurement, and department leaders. Program & Vendor Management Oversee the full lifecycle of the external workforce including sourcing, onboarding, tracking, and offboarding via VMS such as SAP Fieldglass. Manage key vendor relationships (CROs, staffing firms, consultants), ensuring high performance and cost-effectiveness. Partner with regional and functional leads on continuous improvement initiatives. Risk & Compliance Ensure adherence to labor laws, co-employment risks, GxP, and FDA/EMA requirements. Serve as process owner for SOX audits, including execution of monthly controls and support for audit readiness. Technology & Analytics Lead development of dashboards and reporting tools (e.g., Tableau, Alteryx) to monitor cost, utilization, and workforce trends. Provide insights and recommendations to senior leadership to inform strategic workforce planning. Stakeholder Engagement & Team Leadership Act as a trusted advisor to business leaders across various functions. Mentor and manage a team (where applicable), and champion process standardization, scalability, and operational excellence. Support change management, training, and policy adherence across the organization. Win - What We Expect of You Bachelor s degree in Human Resources, Business, Life Sciences, or related field (MBA or MS preferred). 8-12 years of experience managing external workforce programs, with 3+ years in life sciences or biotech preferred. Deep expertise in contingent workforce models and VMS tools (Fieldglass, Beeline). Strong knowledge of regulatory and compliance frameworks (e.g., SOX, GxP, FDA). Proven success leading cross-functional programs and influencing senior stakeholders. Thrive - What You Can Expect from Us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. We offer competitive annual base salary, and a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. .

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4.0 - 9.0 years

35 - 40 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. We are seeking a strategic and execution-focused GV&A Amgen India Leader to play a critical leadership role in the growth and evolution of our Innovation Center. In this vital role you will be responsible for building new functional capabilities, transitioning existing work, and insourcing work from external vendors to drive operational excellence, cost efficiency, and innovation. This role is part of the Global HEOR Leadership Team. Lead Capability Design and Stand-Up Define and execute a phased roadmap to establish new functional capabilities within the innovation center across Value & Access or other relevant business areas. Partner with global functional leaders to assess current state operations, identify transition candidates, and co-design future-state workflows. Manage Work Transition and Insourcing Develop and oversee transition plans to migrate work from internal global teams to the innovation center with minimal disruption. Lead the insourcing of services currently delivered by external vendors, ensuring appropriate knowledge transfer, risk mitigation, and operational readiness. Build and Develop High-Performing Teams Hire, onboard, and develop talent required to deliver on newly created capabilities. Instill a culture of collaboration, continuous improvement, and accountability within the innovation center team. Drive Cross-Functional Engagement and Alignment Act as a key liaison between the innovation center and business units globally, ensuring alignment on goals, processes, and success measures. Facilitate stakeholder alignment across regions and functions to support smooth transitions and integration of new ways of working. Monitor Progress and Optimize Delivery Track key performance metrics and transformation milestones, regularly reporting progress to senior leadership. Identify and resolve roadblocks, process gaps, and resourcing needs as part of continuous improvement efforts. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The ideal candidate will be a skilled change agent with deep experience in Value and Access as well as HEOR, organizational transformation, capability development, and cross-functional collaboration. This role offers the opportunity to help shape the future operating model of a high-impact global organization. Basic Qualifications & Experience: Doctorate degree in Business, Operations, Health Economics or Life Sciences and 4 years of experience as V&A leader, having worked across HEOR, pricing and access strategy, either in life sciences or consulting OR, Master s degree in Business, Operations, Health Economics or Life Sciences and 14 to 16 years of experience as V&A leader, having worked across HEOR, pricing and access strategy, either in life sciences or consulting OR, Bachelor s degree in Business, Operations, Health Economics or Life Sciences and 16 to 18 years of experience as V&A leader, having worked across HEOR, pricing and access strategy, either in life sciences or consulting. Proven experience in standing up new teams, managing, and retaining talent in India Demonstrated success in managing complex transitions, including work insourcing and internal capability shifts. Strong leadership, stakeholder management, and communication skills. Ability to thrive in a fast-paced, ambiguous environment and drive clarity through structured problem-solving. Excellent English oral and written communication Comfortable working in a global team across time zones and cultures. Preferred Experience Prior experience working in or with a global innovation or shared services center. Knowledge of change management principles and tools (e.g. Prosci, ADKAR). 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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2.0 - 7.0 years

13 - 17 Lacs

Hyderabad

Work from Office

Lets do this. Lets change the world. In this vital role you will be reporting to the Senior Manager, Corporate Learning Programs, where the Manager will serve as a learning professional and client interface for all corporate functions (HR, Law, etc.) In that capacity, the Manager is responsible for: Work closely with our annual processes and platform to connect learning solutions and programs with Amgen s individual- and manager-effectiveness priorities Understanding our corporate clients business drivers and working with them to define and execute long-range performance strategies Partnering with the client on needs analyses that provide a comprehensive look at performance opportunities and barriers and that define the scope and deliverables of specific training solutions Shepherding those specific learning projects through the governance and intake process Acting as a design consultant while supporting both the client and Amgens internal training development team during the life of a training solution project Working alongside fellow team members to define and enhance the instructional and interactive strategies of our core enterprise development products: Learning for Growth and Amplifying Manager Performance Collaborating with Global Learning Solutions and Amgens IS/IT team to help define a technology roadmap for enterprise learning The Manager will be the liaison between our Talent team and Amgens internal learning development and technology team. In that role, the Manager will work with Amgens Global Learning Solutions Team to help define the learning ecosystem and technology infrastructure. The Manager will need to be versed in learning platforms and tools, digital strategy and marketing, and in current trends in the broader learning space. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Corporate Learning Programs Manager professional we seek will have these qualifications. Basic Qualifications: Doctorate degree OR Masters degree and 2 years of Talent, Learning and Development, or Instructional Design experience Or Bachelors degree and 4 years of Talent, Learning and Development, or Instructional Design experience Or Associates degree and 10 years of Talent, Learning and Development, or Instructional Design experience Or High school diploma / GED and 12 years of Talent, Learning and Development, or Instructional Design experience Preferred Qualifications: Experience in instructional design, human performance technology, learning systems & platforms, life sciences, or business Experience with performance consulting and needs analysis eLearning design experience and a broad knowledge of learning technology, learning experience platforms, internal talent marketplaces, and other virtual platforms Experience using Agile or other design and development methodologies in the creation of learning solutions Experience in project management (managing projects, defining scope, overseeing budget, tracking milestones) Effective communication and writing skills Ability to work with staff across multiple levels of an organization Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible

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4.0 - 9.0 years

4 - 8 Lacs

Hyderabad

Work from Office

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Job Summary: Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases. Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements. Provide vendors with resources and training to perform their role. Responsible for raise of device/combination product case related issues. Providing audit/inspection support for case management related activities including liaising with vendors to provide support as applicable for device/combination products. Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness. May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable. Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor. Key Activities: Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Ensures compliance and timely reporting with device/combination product cases through query process. Contributes to the implementation of new intake-related systems, processes and procedures within the process. Supports an engaging culture. Ensures quality of PC, AE and OSF records. Applies analytical skills to evaluate moderately complex situations using multiple sources of information while applying multiple systems. Implements Standard Operating Procedure requirements for device/combination product cases. Develops solutions to technical problems up to moderate complexity. Knowledge and Skills: Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices). Familiarity with clinical development process. Demonstrating high case level productivity and quality. Attention to detail. Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 4 years of Drug Safety or Life Sciences experience OR Master s degree and 7 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 9 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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