PHARMAFull-time
Specialist IS Engineer - System Implementation & Development
HYDERABAD (IN)ONSITEPOSTED: 8/28/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Design, develop, and maintain software applications and solutions that meet business needs while ensuring availability and performance of critical systems and applications.
Serve as a technical functional lead/developer for Clinical Risk Based Monitoring (RBM) and Risk Based Quality Management (RBQM) system implementation within the Clinical Trial Operations and Site Engagement (CTOSE) product team.
Participate in technical discussions concerning RBQM systems and take ownership of complex software projects from conception through deployment.
Build technical solutions according to implementation project plans while collaborating with product-team members and business partners.
Apply hands-on expertise in application/system integrations and backend development.
Rapidly prototype concepts and translate them into working code while managing software-delivery scope, risks, and timelines.
Contribute to front-end, back-end, and integration development using cloud technologies and generative AI.
Conduct user acceptance testing with customers, coordinate feedback, resolve issues, and obtain study acceptance.
Support requirements gathering and specification creation for development work.
Communicate risks and contingency plans to project management and ensure compliance with regulatory and Amgen procedural requirements.
Contribute to process, product, and standard-methodology initiatives and support developers and testers throughout the project lifecycle.
Define, author, and present Business, Logical, Integration, Security, Infrastructure, and other architecture footprints.
Create and maintain detailed documentation covering software architecture, design, deployment, disaster recovery, and operations.
Conduct code reviews to maintain code quality and adherence to development best practices.
Identify and resolve technical challenges, bugs, and issues within deadlines.
Work with product management, design, QA, and other multifunctional teams to deliver high-quality software on schedule.
Technical & Domain Expertise
Strong software-development background covering development processes, application/system integrations, databases, and cloud-based content systems.
Python scripting, SQL queries, XML, JSON, MuleSoft, Databricks, APIs, and API-driven content delivery.
Cloud platforms including AWS, GCP, and Azure, with containerization technologies such as Docker and Kubernetes.
Data-processing technologies such as Hadoop and Spark or similar platforms.
Knowledge of pharmaceutical domain processes and clinical trials.
Understanding of Risk Based Quality Management for clinical trials.
Familiarity with international pharmaceutical regulatory submission guidelines and processes including eCTD, ICH, CDS, and USPI.
Basic understanding of Generative AI solutions.
Agile & Product Delivery
Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements.
Experience with product backlog management and collaboration tools such as Jira.
Ability to manage software delivery scope, risk, timelines, requirements, testing, deployment, and operational documentation.
Qualifications & Experience
Bachelor's or Master's degree with 8-12 years of experience in Computer Science.
Strong problem-solving and analytical abilities.
Ability to learn quickly and work independently with a high degree of initiative and self-motivation.
Excellent verbal, written, interpersonal, presentation, and public-speaking skills.
Ability to manage multiple priorities and work effectively with global virtual teams.
Leadership & Business Impact
Lead technical implementation activities for clinical RBQM systems and translate business concepts into scalable technology solutions.
Coordinate across product management, design, QA, developers, testers, customers, and business partners.
Ensure technical delivery aligns with regulatory, quality, security, architecture, and Amgen procedural requirements.
Provide technical guidance through architecture definition, code reviews, troubleshooting, testing, documentation, and delivery management.
Company & Total Rewards
Amgen describes its mission as serving patients living with serious illnesses and highlights its work across oncology, inflammation, general medicine, and rare disease.
Amgen states that it provides competitive and comprehensive Total Rewards plans aligned with local industry standards in addition to base salary.
The company promotes a collaborative, innovative, science-based culture and emphasizes professional and personal growth and well-being.
Amgen is an Equal Opportunity employer and states that reasonable accommodation is available during recruitment and employment.
REQUIRED VERIFIED SKILLS
Software Development
System Implementation
Clinical Risk Based Monitoring
Risk Based Quality Management
Clinical Trial Operations
Application Integration
Backend Development
Frontend Development
C#
Python
SQL
XML
JSON
MuleSoft
Databricks
APIs
Cloud Technology
AWS
GCP
Azure
Docker
Kubernetes
Agile
Scrum
Jira
Pharmaceutical Domain
Clinical Trials
eCTD
ICH
USPI
Software Architecture
Code Review
User Acceptance Testing
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
RECOMMENDED TRAINING
1/5
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