6597 - Senior Business Analyst, AI-Assisted Regulatory Authoring

United States·Cambridgesenior

Business AnalystData & AI

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Quick Summary

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,

Requirements Summary

Lead business analysis for an AI-enabled CMC regulatory authoring technology implementation Translate CMC regulatory-authoring workflows into business, functional, data, integration, security,

Technical Tools

Business AnalystData & AI

Description

We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Responsibilities

~1 min read

→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

~2 min read

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
Experience implementing AI/GenAI, intelligent content automation, regulatory technology, or comparable emerging technology solutions strongly preferred
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.

*Verista is an equal opportunity employer.

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

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

For more information about our company, please visit us at Verista.com

Location & Eligibility

Where is the job

Cambridge, United States

On-site at the office

Who can apply

About this job

Pay per year: $90,039–$136,225 a year; 8% above the $105,000 median for Business Analyst jobs on Jobera (217 salaries).
Who can apply: United States
Posted: Today
Employer: has 57 open jobs on Jobera.