Senior Specialist, Technical Product Analyst

Merck & Co.; West Point (PA); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) retirement plan

Job summary

Merck & Co. in the United States is seeking a Senior Specialist, IT for the RDLM Product Team to support regulatory lifecycle management and document control capabilities.

You will elucidate business needs, translate them into actionable requirements, and partner with IT, business, and vendors to deliver compliant digital solutions. The role emphasizes requirements management, SDLC adherence, process analysis, and collaboration across teams to optimize regulatory operations.

Qualifications

• Bachelor's degree required in IT, business, CS, or related field.
• 5+ years of product or business analysis experience in life sciences/healthcare recommended.
• Strong SDLC knowledge with Agile, Waterfall, and Kanban.
• Excellent communication and stakeholder management skills.

Responsibilities

• Partner with stakeholders, product owners, IT teams and vendors to understand needs and regulatory processes.
• Gather and document requirements, flows, user stories, acceptance criteria, and specs.
• Translate business needs into clear solution requirements for teams.
• Support roadmap execution by aligning scope, priorities, releases, and capabilities.
• Analyze current-state processes for simplification, standardization, and automation.
• Develop understanding of data flows for regulatory submissions and archive capabilities.
• Use JIRA to manage requirements, traceability, and progress across the project.
• Stay updated on regulatory tech trends to drive innovation and improvement.

Skills

Change Catalyst

Cloud Computing

Customer-Focused

Demand Management

End User Computing

Group Policy Management

ITIL Service Delivery

IT Infrastructure Management

Network Administration

OOP Concepts

Professional Etiquette

Server Hardware Configuration

Software Development

Sourcing Services

Strategic Planning

Education

Bachelor's degree in information technology, Business Administration, Computer Science, or related discipline.

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

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.

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.

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

Flexible Work Arrangements:

Hybrid

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.

Requisition ID:

R414255