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:

Preferred Skills:

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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 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:

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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 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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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. 

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