Senior Specialist, Technical Product Analyst

Job Description

Functional Area: Digital Regulatory & Safety within Clinical Development and Digital Solutions (CDDS)

The Regulatory Document Lifecycle Management Product Team serves as a strategic business partner, collaborating across IT, business, and vendor teams to deliver innovative digital capabilities that support Regulatory Operations and improve business productivity. We are seeking a detail-oriented and highly motivated Technical Product Analyst with a strong blend of product analysis, business analysis, technical aptitude, and domain knowledge. This role will support the ongoing delivery, optimization, and growth of regulatory lifecycle and document management capabilities, with a focus on business process analysis, requirements management, solution configuration awareness, SDLC adherence, and delivery of high-quality outcomes in a regulated environment.

Senior Specialist, IT – RDLM Product Team

Job Summary

The RDLM Product Team serves as a strategic business partner, collaborating across IT, business, and vendor teams to deliver innovative digital capabilities that support Regulatory Operations and improve business productivity. We are seeking a detail-oriented and highly motivated Senior Specialist, IT with a strong blend of product analysis, business analysis, technical aptitude, and domain knowledge. This role will support the ongoing delivery, optimization, and growth of regulatory lifecycle and document management capabilities, with a focus on business process analysis, requirements management, solution configuration awareness, SDLC adherence, and delivery of high-quality outcomes in a regulated environment.

Primary Responsibilities

• Partner with business stakeholders, product owners, IT teams, and vendors to understand business needs, product priorities, and end-to-end regulatory lifecycle and document management processes.
• Gather, analyze, and document business requirements, process flows, user stories, acceptance criteria, and functional specifications to support product capabilities and enhancements.
• Serve as a liaison between business and technical teams, translating business needs into clear, actionable solution requirements.
• Support product roadmap execution by collaborating with product management and delivery teams to align scope, priorities, releases, and technical capabilities.
• Analyze current-state processes and identify opportunities for simplification, standardization, automation, and continuous improvement.
• Develop a comprehensive understanding of business processes and data flows, including inputs and outputs, related to Veeva RIM Submissions and Archive capabilities.
• Utilize JIRA to manage requirements, track work items, support traceability, and document delivery progress throughout the project lifecycle.
• Stay informed about industry trends, best practices, and emerging capabilities in regulatory and life sciences technology, and apply this knowledge to help drive product innovation and continuous improvement.

Qualifications

• Bachelor’s degree in information technology, Business Administration, Computer Science, or related discipline.
• Minimum of 5 years of relevant experience in product analysis or business analysis, preferably within the life sciences or healthcare industry.
• Proven track record of managing complex projects and working collaboratively in cross-functional teams.
• Strong understanding of the software development lifecycle (SDLC) and delivery methodologies, including Agile, Waterfall, and Kanban.
• Excellent communication and interpersonal skills, with the ability to tailor messages to different audiences and build strong working relationships.
• Hands-on experience with a Regulatory Information Management system(s).
• Experience with JIRA for backlog management, requirements tracking, and delivery documentation.
• Familiarity with GxP, GMP, and best practices for implementing and maintaining highly compliant systems.

Preferred Qualifications

• Hands-on experience with Veeva RIM is highly desirable.
• Familiarity with regulatory lifecycle management, health authority interactions, or related regulatory operations processes.
• Project management, Agile, Product Owner, Business Analysis, or Veeva-related certification is a plus.
• Strong analytical mindset with effective problem-solving skills.

SWE2026

Required Skills:

Change Catalyst, Cloud Computing, Customer-Focused, Demand Management, End User Computing, Group Policy Management, ITIL Service Delivery, IT Infrastructure Management, Network Administration, Object-Oriented Programming (OOP) Concepts, Server Hardware Configuration, Software Development

Preferred Skills:

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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