Senior Specialist, Technical Product Analyst

Description

The regulatory document lifecycle management product team works as a business partner across IT, business and vendor groups to deliver digital tools that support Regulatory Operations and raise productivity.

This is a Senior Specialist, IT role in Digital Regulatory and Safety, part of Clinical Development and Digital Solutions (CDDS), with requisition code SWE2026.

You will help keep regulatory lifecycle and document management capabilities running, improving and expanding in a regulated setting, with a focus on process analysis, requirements, solution configuration awareness and SDLC practice.

Responsibilities

• Work with business leads, product owners, IT staff and vendors to pin down business needs, product priorities and the full regulatory lifecycle and document processes.
• Collect and write up business requirements, process flows, user stories, acceptance criteria and functional specifications for product features and changes.
• Translate business needs into clear, workable solution requirements, linking business and technical teams.
• Help deliver the product roadmap by aligning scope, priorities, releases and technical capability with product management and delivery teams.
• Review current processes to find chances to simplify, standardise, automate and keep improving.
• Build a thorough understanding of business processes and data flows, including inputs and outputs, for Veeva RIM Submissions and Archive capabilities.
• Keep requirements in JIRA, log work items, maintain traceability and record delivery progress across the project lifecycle.
• Follow industry trends and new capabilities in regulatory and life sciences technology, and bring relevant ideas that drive product innovation.

Requirements

• Bachelor's degree in information technology, business administration, computer science or a related field.
• At least 5 years in product or business analysis, ideally in life sciences or healthcare.
• Track record of running complex projects and working well in cross-functional teams.
• Solid grasp of the SDLC and delivery approaches including Agile, Waterfall and Kanban.
• Clear communication and relationship skills, adapting messages to different audiences.
• Hands-on work with at least one Regulatory Information Management system.
• Experience using JIRA for backlog management, requirements tracking and delivery documentation.
• Knowledge of GxP, GMP and practices for building and keeping highly compliant systems.
• Preferred: hands-on Veeva RIM experience, highly desirable.
• Preferred: familiarity with regulatory lifecycle management, health authority interaction or regulatory operations processes.
• Preferred: certification in project management, Agile, Product Owner, business analysis or Veeva, a plus.
• Preferred: strong analytical thinking and problem solving.
• Required skills include 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.

Conditions

Hybrid working arrangement, based in North Wales (Upper Gwynedd), Pennsylvania, USA, with a regular employee status.

Base salary for the primary location is $117,000.00 to $184,200.00, with placement based on education, qualifications, certifications, experience, skills, location, government requirements and business needs.

Eligible for annual bonus and long-term incentive where applicable.

Pay for other listed locations may follow different guidelines, and those ranges are given by the talent team on request.

Visa sponsorship, relocation, travel, shift, driving licence and hazardous material details are not stated in the posting.

Applications close at 11:59:59 PM on 11/09/2026, the day before the 11/10/2026 end date.

The company does not accept unsolicited CVs from search firms without a written agreement, and no fee applies to unsolicited referrals.

The company is an equal-opportunity employer, considers San Francisco applicants with arrest or conviction records under local law, and offers accommodations during hiring on request.

Benefits

• Medical, dental and vision cover, plus other insurance for employees and their families.
• Retirement benefits including a 401(k) plan.
• Paid holidays, vacation, compassionate leave and sick days.