Summer Internship: GxP Surveillance… at BeOne Medicines · Remote

Summary: BeOne Medicines is a rapidly growing company focused on fighting cancer, and they are seeking a GxP Surveillance Intern to provide support in monitoring regulatory GxP requirements. The role involves daily screening of regulations and generating reports for assessment by subject matter experts. Responsibilities: - Provide support to GxP Surveillance and GxP Intelligence Management System - Actively and meticulously monitoring regulatory GxP requirements and expectations - Daily screening and gathering new & changed regulations, guidance, trends, intelligence and regulatory enforcement activities with potential impact to BeOne products, processes and business in its priority markets - The source of regulatory / GxP Intelligence for daily screening are news organizations, subscription-based databases, scientific organizations such as PDA, ISPE, etc., Global Regulatory Agencies websites, International Organization websites e.g., ICH, WHO, PIC/S - Generation of daily reports for further assessment by the Triage Leads and subject matter experts from various GxP functions - The regulatory surveillance on GxP (GLP, GCP, GVP, GMP, GDP/GSP, Pharmacopeia, Medical Device and Diagnostics, Drug-Device Combination product, Chemistry Manufacturing, Control (CMC), Supply Chain and Good AI Practice) - Efficient web searing and source evaluation - Navigating regulatory authority websites (US FDA, EMA, PMDA, WHO, ICH, Pharmacopeia) Monitoring updates, guidance documents, health authority notifications, alerts, and public consultation documents - Document management – file organization and version control Required Qualifications: - Bachelor's degree in progress: Life Sciences, Pharmacy, Biomedical, Chemical engineering related degree - Basic computer skills – MS Office / Microsoft 365, Excel, PowerPoint, Outlook - Collaboration Tools – MS Teams, SharePoint, OneDrive (basic use for the file sharing and collaboration) - Attention to detail in data capture and documentation - Maintaining logs, trackers, and simple databases for regulatory surveillance - Strong organizational skills - Ability to interpret, synthesize, and communicate information - English communication skills both written and oral - Ability to understand technical, scientific and medical information - Ability to prioritize, demonstrating good time management skills - Self-motivated, with the ability to work proactively using own initiative - Committed to learning and development Preferred Qualifications: - Familiarity with regulatory intelligence platforms (e.g., Cortellis, Redica, Citeline, InfoDesk, FDA and EMA databases) Required Skills: GxP Surveillance, Regulatory Intelligence Important Skills: Data Analysis, MS Office Nice-to-Have Skills: English Communication, Attention to Detail, Organizational Skills, Self-Motivated, Time Management, Teamwork Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness