BeOne Medicines · 20 hours ago
Summer Internship: GxP Surveillance Intern (Remote)
United States
Internship
Remote
Intern
$27/hr - $27/hrBeOne 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.
Pharmaceuticals
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
Qualification
Required
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
Familiarity with regulatory intelligence platforms (e.g., Cortellis, Redica, Citeline, InfoDesk, FDA and EMA databases)
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
Founded in 2010
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase