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.

** 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:

*
* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** 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…