Bachelor's degree in Life Sciences, Chemistry, Biology, Computer Science, Information Systems, or related field; advanced degree preferred
7+ years as a business analyst with experience in pharmaceutical technology solutions
Strong skills in requirements elicitation, process mapping, and user stories
Familiarity with Agile methodology, Jira, and Confluence
Understanding of CMC regulatory documentation and CTD/eCTD Module 3
Experience collaborating with CMC scientists and regulatory stakeholders
Ability to translate complex scientific processes into technology requirements
Responsibilities
Lead business analysis for AI-enabled CMC regulatory authoring technology
Translate regulatory-authoring workflows into comprehensive requirements
Support the full SDLC from discovery to post-implementation
Collaborate with scientists and engineers to identify automation opportunities
Define use cases for Generative AI and content automation
Develop user stories, acceptance criteria, and UAT scenarios
Participate in solution design, challenge assumptions, and recommend solutions
Benefits
High growth potential in a fast-paced, people-focused culture
Competitive pay with performance-based incentives
Company-paid Life, Short-Term, and Long-Term Disability Insurance
Comprehensive Medical, Dental & Vision insurances
Flexible Spending Accounts and Commuter Benefits
401(k) Retirement Plan with Employer Matching
Paid Time Off with rollover option and holidays
Tuition Reimbursement and team social activities
Employee Recognition and Referral Program
Paid Parental Leave and Bereavement support
Full Job Description
Job Overview: We are seeking an experienced Senior Business Analyst to support the end-to-end deployment of an AI-enabled CMC regulatory authoring solution, focused on automation and AI-assisted authoring of CTD/eCTD Module 3 Quality content for NDA/BLA submissions. The consultant will bridge Regulatory CMC scientists/engineers, Quality, IT, AI/Data teams, and technology vendors, translating scientific and regulatory authoring processes into technology requirements and driving business-facing activities across the IT System Development Life Cycle (SDLC)..
Key Responsibilities:
Lead business analysis for an AI-enabled CMC regulatory authoring technology implementation
Translate CMC regulatory-authoring workflows into business, functional, data, integration, security, and non-functional requirements
Support the full SDLC, including discovery, requirements, solution design, build/configuration, testing, UAT, deployment, and stabilization
Partner directly with Regulatory CMC, scientists, process engineers, and analytical scientists to identify and prioritize authoring automation opportunities
Define use cases and requirements for Generative AI, LLM/RAG, source-grounded content generation, structured/tabular content automation, content reuse, provenance, and human-in-the-loop review
Develop user stories, acceptance criteria, process flows, UAT scenarios, and requirements traceability
Define and execute business acceptance criteria for AI-generated CMC content, including accuracy, completeness, consistency, source alignment, and traceability
Participate actively in solution-design decisions, challenge assumptions, identify gaps, and recommend practical solutions rather than simply documenting requirements
Support applicable pharmaceutical IT validation/assurance, deployment readiness, go-live, and post-implementation stabilization
Requirements:
Bachelor's degree in Life Sciences, Chemistry, Biology, Computer Science, Information Systems, or a related field; advanced degree a plus
7+ years of experience as a business analyst, with demonstrated experience delivering pharmaceutical technology solutions through a formal IT SDLC
Strong Business Analysis skills, including requirements elicitation, process mapping, user stories, acceptance criteria, UAT, defect management, and requirements traceability
Experience with Agile methodology, sprints, Jira and Confluence
Practical understanding of CMC regulatory documentation and CTD/eCTD Module 3, including 3.2.S - Drug Substance and/or 3.2.P - Drug Product, associated structured/tabular CMC information, manufacturing process descriptions, analytical methods, specifications, control strategies, stability information, process validation and characterization information. Candidate should understand how scientific and manufacturing information progresses from source data and technical documentation into CMC regulatory submission content
Experience working with CMC scientists, engineers, analytical scientists, and/or Regulatory CMC stakeholders
Ability to translate complex scientific/regulatory processes into implementable technology requirements
Demonstrated ability to analyze issues, evaluate alternatives, challenge assumptions, and influence solution decisions
Must be on-site in Cambridge, MA 3 days/week at minimum
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
National (US) Range
$90,039-$136,225 USD
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
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For more information about our company, please visit us at Verista.com
About Verista
Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
