Senior Specialist, Technical Product Analyst
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 vendor organizations to deliver digital capabilities that support Regulatory Operations and improve business productivity. The role contributes to the delivery, optimization, and growth of regulatory lifecycle and document management capabilities in a regulated environment, focusing on business process analysis, requirements management, solution configuration awareness, adherence to the software development lifecycle, and high-quality outcomes. The analyst works with stakeholders and delivery teams to translate business needs into actionable product requirements, support roadmap execution, and improve processes. The role involves understanding processes and data flows for Veeva RIM Submissions and Archive capabilities and using JIRA to manage requirements and work items throughout the project lifecycle.
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 the life sciences or healthcare industry.
- Proven track record managing complex projects and collaborating in cross-functional teams.
- Strong understanding of the software development lifecycle 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.
- Required skills listed: 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, and Software Development.
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 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.
- Use 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 product innovation and continuous improvement.
Benefits
- Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
