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IT Infrastructure Demand Management Product Management Product Innovation Workday (Software) Business Etiquette Business Strategies Document Management Software Development Regulatory Documents Contingent Workforce Lifecycle Management Digital Capabilities Business Requirements Waterfall Methodology Information Technology Network Administration Business Administration Requirements Management Pre-Clinical Development Functional Specification Business Process Analysis Interpersonal Communications Good Manufacturing Practices Scrum (Software Development) Systems Development Life Cycle Software Development Life Cycle Object-Oriented Programming (OOP) Hardware Configuration Management Information Technology Infrastructure Library Regulatory Information Management Systems (RIMS), 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., 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., * 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., IT Infrastructure Demand Management Product Management Product Innovation Workday (Software) Business Etiquette Business Strategies Document Management Software Development Regulatory Documents Contingent Workforce Lifecycle Management Digital Capabilities Business Requirements Waterfall Methodology Information Technology Network Administration Business Administration Requirements Management Pre-Clinical Development Functional Specification Business Process Analysis Interpersonal Communications Good Manufacturing Practices Scrum (Software Development) Systems Development Life Cycle Software Development Life Cycle Object-Oriented Programming (OOP) Hardware Configuration Management Information Technology Infrastructure Library Regulatory Information Management Systems (RIMS) +0

Veeva Operations Management Automation Innovation User Story Compassion Group Policy Communication Life Sciences Detail Oriented Self-Motivation Problem Solving Cloud Computing Customer Service Business Process Computer Science Product Roadmaps Telephone Skills Technical Acumen Product Analysis Domain Knowledge Agile Methodology, * 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., * 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, Valid Driving License, Natural Gas Market Area Communication Point Of Sale Data Analysis Professionalism Problem Solving Desktop Support Customer Service Business Process Microsoft Office Computer Science Microsoft Access Customer Support Waste Management Biomedical Waste Technical Issues Operating Systems Technical Support Computer Hardware Energy Production Peripheral Devices Workflow Management Business Strategies Root Cause Analysis Incident Management Docking (Computers) Software Deployment Technical Assistance Remote Access Systems Renewable Natural Gas Information Technology Development Environment Wireless Communications Consultative Approaches Network Troubleshooting Management Information Systems Virtual Private Networks (VPN) Network Performance Management Troubleshooting (Problem Solving)

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.