remote Full-time

BeOne is hiring a Summer Internship: GxP Surveillance Intern (Remote)

About the Role

BeOne is looking for a GxP Surveillance Intern to provide support for our regulatory surveillance and intelligence management systems. In this remote role, you will actively monitor global GxP requirements, screening for new and changed regulations, guidance, trends, and enforcement activities that could impact our products and business.

What You'll Do

  • Conduct daily screening to gather new and changed regulations, guidance, trends, intelligence, and regulatory enforcement activities.
  • Generate daily reports for assessment by Triage Leads and subject matter experts.
  • Perform regulatory surveillance across GxP areas including GLP, GCP, GVP, GMP, GDP/GSP, Pharmacopeia, Medical Devices, Diagnostics, Drug-Device Combinations, CMC, Supply Chain, and Good AI Practice.
  • Efficiently search and evaluate web sources.
  • Navigate regulatory authority websites such as US FDA, EMA, PMDA, WHO, ICH, and Pharmacopeia sites.
  • Monitor updates, guidance documents, health authority notifications, alerts, and public consultation documents.
  • Manage documents through effective file organization and version control.

What We're Looking For

  • Bachelor’s degree in progress in Life Sciences, Pharmacy, Biomedical, Chemical Engineering, or a related field.
  • Basic computer skills with MS Office / Microsoft 365, including Excel, PowerPoint, and Outlook.
  • Experience with collaboration tools like MS Teams, SharePoint, and OneDrive for file sharing.
  • Strong attention to detail in data capture and documentation.
  • Excellent organizational skills.
  • Ability to interpret, synthesize, and communicate complex information.
  • Strong written and oral English communication skills.
  • Ability to understand technical, scientific, and medical information.
  • Skill in prioritizing tasks and managing time effectively.
  • Self-motivated with the ability to work proactively using own initiative.
  • A commitment to learning and development.

Nice to Have

  • Familiarity with regulatory intelligence platforms such as Cortellis, Redica, Citeline, InfoDesk, or FDA and EMA databases.

Technical Stack

  • MS Office / Microsoft 365
  • Excel
  • PowerPoint
  • Outlook
  • MS Teams
  • SharePoint
  • OneDrive

Benefits & Compensation

  • Comprehensive benefits including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs.
  • All employees are eligible for discretionary equity awards.
  • Eligibility to voluntarily participate in the Employee Stock Purchase Plan.
  • Compensation: $27/hour USD.

Work Mode

This is a fully remote summer internship position.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law.

Required Skills
Microsoft 365ExcelPowerPointOutlookMS TeamsSharePointOneDriveGxPRegulatory ComplianceDocumentationCommunicationData Analysis
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BeOne

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Posted a month ago