At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition from leading workplace and culture organizations, including Science's Top Employers, Great Place To Work® in the U.S., and Fortune's Best Workplaces in BioPharma. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Summer Intern – GxP AI Compliance & Documentation on the Information Technology Team to help us expand what’s possible for patients with serious diseases. The Insmed Summer Internship Program is designed to give you more than just a glimpse into the pharmaceutical industry—it’s a chance to make a real impact. Over the course of the summer, you’ll gain hands-on experience, contribute to meaningful team projects, and learn directly from skilled professionals who are invested in your growth. Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship. The internship may present opportunities for rotational assignments within the function, and the intern will be assigned goals and objectives that will support the strategic business plan of the company. What You'll Do: In this role, you’ll have the opportunity to 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. This is a hands-on, mentorship-driven internship designed for curious, hungry learners who want to see how their AI and technology knowledge creates real impact in a highly regulated industry. You'll bring the AI fluency; we'll guide you through the rest. You’ll also: 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 — giving you a portfolio-ready artifact by the end of the summer 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. You are or you have: 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 — that demonstrate an appreciation for structured, governed environments Where You’ll Work This is a hybrid role based out of our Bridgewater, New Jersey Headquarters. You’ll work remotely most of the time, with in-person collaboration when it matters most. Pay Range: $20.00-35.00 Hourly Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. Our internship program reflects that commitment by supporting how you learn, grow, and show up each day while contributing to work that matters. Our internship offerings include: Paid company holidays Hands-on learning in real-world projects Networking opportunities with leaders and social events with your peers Mentorship and professional development A final presentation to celebrate your contributions Access to office amenities for those who are not remote Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled. Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [email protected]. Insmed is a people-first global biopharmaceutical company driven to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, NJ, with locations across the U.S., EMEA, and Japan, we’re guided by our core values and a shared commitment to patients and each other. We’ve been named Science’s No. 1 Top Employer four years in a row, certified as a Great Place to Work in the U.S., and recognized among The Sunday Times’ and BioSpace’s Best Places to Work. For patients, each other, and the future of science, we’re in. Are you? Wherever you are in the world or in your career, we want to stay connected. Sign up for our talent community to hear about new career opportunities, company news, and how our teams around the world are striving to make a difference for patients every day. Sign UP

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