Senior Specialist, Technical Product Analyst

Senior Specialist, IT – RDLM Product Team

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 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.

Preferred Qualifications

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

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, Professional Etiquette, Server Hardware Configuration, Software Development, Sourcing Services, Strategic Planning

Preferred

Skills:

Salary Range: $ - $

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at