Senior Specialist, Technical Product Analyst

MSD•North Wales, PA

4d•$117,000 - $184,200•Hybrid

About The Position

The Senior Specialist, Technical Product Analyst supports the Regulatory Document Lifecycle Management (RDLM) Product Team within Digital Regulatory & Safety, Clinical Development and Digital Solutions. The team partners across IT, business, and vendors to deliver digital capabilities for Regulatory Operations and improve productivity. This role supports the delivery, optimization, and growth of regulatory lifecycle and document management capabilities through business and product analysis, requirements management, solution configuration awareness, adherence to the software development lifecycle, and delivery of quality outcomes in a regulated environment. The role collaborates with stakeholders and delivery teams to understand regulatory processes and product priorities, translate business needs into solution requirements, and support roadmap execution. It also analyzes processes and data flows related to Veeva RIM Submissions and Archive capabilities and contributes to continuous improvement and product innovation.

Requirements

Bachelor’s degree in information technology, Business Administration, Computer Science, or a related discipline.
At least 5 years of relevant experience in product analysis or business analysis, preferably in life sciences or healthcare.
Demonstrated experience managing complex projects and collaborating 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, including the ability to tailor messages to different audiences and build strong working relationships.
Hands-on experience with one or more Regulatory Information Management systems.
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.

Nice To Haves

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

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 for product capabilities and enhancements.
Act as a liaison between business and technical teams, translating business needs into clear, actionable solution requirements.
Support product roadmap execution by working 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 understanding of business processes and data flows, including inputs and outputs, related to Veeva RIM Submissions and Archive capabilities.
Use JIRA to manage requirements, track work items, support traceability, and document delivery progress throughout the project lifecycle.
Monitor industry trends, best practices, and emerging regulatory and life sciences technology capabilities, applying relevant knowledge to product innovation and continuous improvement.