Specialist IS Engineer - System Implementation & Development

Amgen Inc; Hyderabad; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

A global biotechnology company in Hyderabad is seeking a Software Development Lead to design and maintain software applications for Clinical Risk Based Monitoring systems. Ideal candidates will have a Master's or Bachelor's degree and 8-12 years of experience in software development processes, with strong knowledge in cloud technologies, API integrations, and scripting languages like Java or Python. The role requires excellent communication and analytical skills, allowing collaboration with diverse teams to deliver high-quality software solutions.

Qualifications

• 8-12 years of experience in Computer Science.
• Strong problem solving and analytical skills.
• Good knowledge of SQL queries and integration tools.

Responsibilities

• Participate in technical discussions related to RB QM systems.
• Take ownership of software projects from conception to deployment.
• Conduct user acceptance testing and support requirements gathering.

Skills

Software development processes

Application/system integrations

Cloud technology

Problem solving

Scripting languages (Java, Python)

Education

Master's or Bachelor's degree in Computer Science

Tools

Jira

Mulesoft

Databricks

APIs

Job description

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions.

Roles Responsibilities:

• Participate in technical discussions related to the Risk base Quality Management ( RB QM ) system(s) within Clinical Trial Operations and Site Engagement (CT OS E) product team.
• Take ownership of complex software projects from conception to deployment. Build technical solution as per implementation project plan by working with various members of the product team and business partners.
• Possesses strong knowledge and hands-on expertise on application/system integrations and backend development.
• Possesses strong rapid prototyping skills and can quickly translate concepts into working code along with managing software delivery scope, risk, and timeline.
• Contribute to both front-end back-end development and Integrations using cloud technology generative AI.
• Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study.
• Support requirements gathering and specification creation process for the development work.
• Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements.
• Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle.
• Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc.
• Create and maintain detailed documentation on software architecture, design, deployment, disaster recovery, and operations.
• Conduct code reviews to ensure code quality and adherence to best practices.
• Identify and resolve technical challenges/bugs issues effectively within deadlines.
• Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Master's or Bachelors degree with 8 - 12 years of experience in Computer Science.

Preferred Qualifications:

• Solid technical background, including understanding software development processes, application/ system integration s , databases, and cloud-based content systems.
• Strong problem solving, analytical skills; Ability to learn quickly; Excellent communication ( verbal written) and interpersonal skills.
• Good knowledge of scripting language ( Java or Python), SQL queries, markup languages (XML, JSON), integration tools ( mulesoft , databricks , APIs) and familiarity with API-driven content delivery.
• Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements.
• Strong knowledge of P harma domain Clinical Trial processes.
• Experience with product backlog management (e.g., Jira) and collaboration tools.

Good-to-Have Skills:

• Experience with structured content management, content models, and modular content creation.
• Knowledge of Risk based Quality Management for C linical T rials.
• Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.).
• Strong understanding of cloud platforms (e.g., AWS, GCP, Azure) and containerization technologies (e.g., Docker, Kubernetes).
• Experience with data processing tools like Hadoop, Spark, or similar.
• Basic understanding of GenAI solutions.
• Good communication skills, with the ability to convey complex technical concepts.

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.