6597 - Senior Business Analyst, AI-Assisted Regulatory Authoring

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

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

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

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

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