Senior Specialist, Technical Product Analyst

MSD Malaysia; North Wales (Montgomery County); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement benefits

Paid holidays and vacation

Sick days and Compassionate leave

Job summary

Merck & Co., Inc. in the United States seeks a Senior Specialist, IT for the RDLM Product Team to drive regulatory lifecycle and document management capabilities.

You will analyze business needs, translate them into technical requirements, and collaborate with IT, business, and vendor teams to deliver compliant digital solutions. The role requires 5+ years in product or business analysis, strong SDLC knowledge, and experience with JIRA and Veeva RIM.

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.
• Proven track record of managing complex projects and working in cross-functional teams.
• Strong understanding of SDLC and delivery methodologies (Agile, Waterfall, Kanban).
• Excellent communication and interpersonal skills, with ability to tailor messages to audiences.

Responsibilities

• Partner with business stakeholders, product owners, IT teams, and vendors to understand business needs 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.
• Serve as a liaison translating business needs into actionable solution requirements.
• Support product roadmap execution with product management and delivery teams.
• Analyze current-state processes to identify opportunities for simplification, standardization, and automation.
• Develop understanding of business processes and data flows related to Veeva RIM Submissions and Archive capabilities.
• Utilize JIRA to manage requirements, track work items, and document progress throughout the project lifecycle.
• Stay informed on industry trends and best practices in regulatory and life sciences tech.

Skills

Regulatory IT

Product analysis

Business analysis

SDLC knowledge

Agile

JIRA

Veeva RIM

Cross-functional

Communication

Education

Bachelor’s degree in IT/Business/CS

Tools

JIRA

Veeva RIM

Job description

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 Current Contingent Workers apply HERE 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 capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As an employer who d

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement 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. Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $117,000.00 - $184,200.00 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 employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 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. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 09/10/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.