Summer Intern – GxP AI Compliance & Documentation
Insmed Incorporated
Summary
We're looking for a Summer Intern – GxP AI Compliance & Documentation on the Information Technology Team. Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship.
Job description
About the Role
We're looking for a Summer Intern – GxP AI Compliance & Documentation on the Information Technology Team. Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship.
What You'll Do
Immerse yourself in the world of regulated technology — learning directly from experienced CSV and GxP professionals how AI systems are validated, documented, and governed in a leading global biopharmaceutical company.
- Shadow and collaborate with full-time CSV professionals to learn how GxP validation principles are applied to software systems across the drug development lifecycle
- Explore and synthesize regulatory guidance (FDA, EMA, GAMP 5, ICH Q9/Q10, EU AI Act) to identify documentation requirements specific to AI and machine learning systems used in GxP contexts
- Analyze existing Insmed AI use cases (e.g., AI-assisted document authoring tools, AI classifiers) to benchmark current documentation practices against emerging regulatory expectations
- Design and develop reusable documentation templates and checklists covering key AI validation touchpoints — model risk assessment, training data governance, explainability, and performance monitoring — aligned to Insmed's CSV SDLC lifecycle phases
- Contribute to a meaningful capstone project — a proposed AI documentation framework that maps AI system characteristics to CSV lifecycle deliverables
- Present findings and deliverables to the CSV leadership team at the conclusion of the internship, with recommendations for adoption into Insmed's CSV SOP/WI framework
Who You Are
You are a current student working on a Bachelor's or Master's degree in Computer Science, Artificial Intelligence / Machine Learning, Data Science, Biomedical Engineering, or a related technical field.
- Foundational knowledge of AI/ML concepts — including model training, validation, explainability (XAI), and common deployment architectures — and the ability to translate technical nuances into structured documentation requirements
- Strong analytical and writing skills, with the ability to organize ideas into clear, structured documents, checklists, or templates using MS office tools
- Basic experience or coursework in software development life cycles (SDLC), software testing methodologies, or systems engineering
- A learning mindset and eagerness to ask questions and research topics
Nice to have (but not required)
- Familiarity with documentation or quality management tools (e.g., MS Word, PowerPoint, Excel, Adobe PDF, SharePoint, Veeva Vault or similar DMS platforms)
- Any exposure to regulatory or compliance concepts — even from adjacent fields like healthcare IT, fintech, or cybersecurity
Requirements
- Current student pursuing a Bachelor's or Master's degree in Computer Science, Artificial Intelligence / Machine Learning, Data Science, Biomedical Engineering, or a related technical field
- Foundational knowledge of AI/ML concepts including model training, validation, explainability (XAI), and common deployment architectures
- Ability to translate technical nuances into structured documentation requirements
- Strong analytical and writing skills
- Ability to organize ideas into clear, structured documents, checklists, or templates using MS Office tools
- Basic experience or coursework in software development life cycles (SDLC), software testing methodologies, or systems engineering
- A learning mindset and eagerness to ask questions and research topics
Benefits
- Paid company holidays
- Hands-on learning
- Networking opportunities
- Mentorship
- Professional development
- Office amenities access
Company overview
Insmed Incorporated is a people-first global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, New Jersey, with offices and research locations throughout the United States, Europe, and Japan, the company focuses on delivering first- and best-in-class therapies for underserved patient communities. Insmed's portfolio includes two approved therapies for chronic lung diseases: ARIKAYCE for Mycobacterium avium complex lung disease and BRINSUPRI for non-cystic fibrosis bronchiectasis. The company is advancing a diverse pipeline of mid- to late-stage investigational medicines and cutting-edge drug discovery programs spanning gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue technologies. Recognized as the No. 1 Science Top Employer for five consecutive years, Insmed employs 1,001-5,000 professionals globally and maintains a strong commitment to innovation, patient-centricity, and corporate responsibility.