Senior Specialist, Technical Product Analyst
MSD
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.
Job description
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.
- Hands-on experience with a Regulatory Information Management system(s).
- 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.
Preferred Qualifications
- Hands-on experience with Veeva RIM is highly desirable.
- Familiarity with regulatory lifecycle management, health authority interactions, or related regulatory operations processes.
- Project management, Agile, Product Owner, Business Analysis, or Veeva-related certification is a plus.
- Strong analytical mindset with effective problem-solving skills.
Requirements
- 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 a Regulatory Information Management system(s).
- 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.
- Hands-on experience with Veeva RIM is highly desirable.
- Familiarity with regulatory lifecycle management, health authority interactions, or related regulatory operations processes.
- Project management, Agile, Product Owner, Business Analysis, or Veeva-related certification is a plus.
- Strong analytical mindset with effective problem-solving skills.
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.