Specialist Software Engineer

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.

• Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement (CTMME) product team.
• Build technical solution per implementation project plan by working with various members of the product team and business partners.
• 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 documentation on software architecture, design, deployment, disaster recovery, and operations.
• Identify and resolve technical challenges/bugs effectively .
• Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time.

Basic Qualifications:

• Masters degree with 4 - 6 years of experience in Computer Science
• Bachelors degree with 6 - 8 years of experience in Computer Science
• Diploma with 10 - 12 years of experience in Computer Science.

• Solid technical background, including understanding software development processes, databases, and cloud-based content systems.
• Experience with Python scripting, SQL queries, markup languages (XML, JSON) and familiarity with API-driven content delivery.
• Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements.
• Experience with product backlog management (e.g., Jira) and collaboration tools.

• Experience with structured content management, content models, and modular content creation.
• Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.)
• Basic understanding of GenAI solutions.
• Good communication skills, with the ability to convey complex technical concepts.

• 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.