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

• Bachelors 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.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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