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   Regulatory Compliance

Collaborating Office

The Vaccine and Immunotherapy Center
Massachusetts General Hospital (East), Bldg 149 Charlestown Navy Yard

Mission: The Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital seeks to improve human health by accelerating the development of new broadly applicable, safe and cost effective vaccines and immune-based therapeutics. We focus on enhancing the speed and effectiveness by which these drugs and vaccines are advanced from laboratory discovery to clinical development, on promoting an understanding of the need for accelerated development of new medical treatments, and on training the next generation of scientists to continue this important work. A crucial component of translation is moving new vaccines and immunotherapies through the regulatory pathway toward clinical testing.

Overall Goal: Working closely with VIC leadership on a specific preclinical-stage technology, the intern will contribute to the development of a briefing document that will form the basis for a pre-pre-IND meeting with the Food and Drug Administration (FDA). Intern will gather information from internal and external sources to contribute to the briefing document. During the project, the intern will engage with the technology development team, including scientists, project managers, and regulatory experts, and industry partners.

Specific learning goals:

  • Acquire first-hand knowledge and experience on the regulatory pathway for drugs and devices.

Potential Projects

Note: Project details may change based on the needs of the collaborating office.

  • Conduct research on regulatory pathway for specific technology and identify information needed for briefing document.
  • Contribute to draft of briefing document that will be used for a pre-pre-IND meeting with the FDA around a specific technology under preclinical development at VIC.
  • Attend lab meetings and briefing meetings with development team.
  • Present results of work to VIC at laboratory meeting.

General Information

  • This opportunity is unpaid.

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For questions, please contact

Graduate Student DivisionPost Doctoral Division Center for Faculty Development Office for Women's Careers Office for Research Career Development