Oncology Regulatory Interns
About The Position
We are seeking junior and senior undergraduate or PharmD students majoring in Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering, or a related field for three full time 12-Week Student Intern roles in Gaithersburg, MD for a May 18th - August 7th contract period. Position Duties: This posting has three openings for the below teams: Regulatory Oncology TA Center of Excellence: Help with gathering of data for IVDR (in-vitro diagnostics regulation)/GMO (genetically modified organisms) metrics. Support an update of GMO regulatory country requirements including research of publicly available information. Support EUDAMED (European database on Medical Devices) implementation. Support SDTL (submission delivery team leads) Academy AI agent creation. Oncology Regulatory Intelligence: Support data validation activities in our digital tool for oncology regulatory approval information. Help with presentation of regulatory intelligence data analyses using AI tools. Undertake background literature research for regulatory intelligence queries using publicly available and commercial tools. Research and analyze regulatory guidance, precedence to support our products and development pipeline CMC RA Devices and Digital Therapeutics Team: Assess and improve select existing regulatory processes for medical devices and combination products. Apply lean principals to understand current process needs, address stakeholder input, implement changes, and propose effectiveness checks. Re-brand and launch agreed process improvements. Relevant examples of regulatory processes may include medical device software classification assessment, medical device registration and listing, and unique device identification.
Requirements
- Junior and senior undergraduate or PharmD students majoring in a Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering or a related field
- Candidates must have an expected graduation date after August 2026
- Experience with data analysis, presentation skills, and ability to search in external sources required
- US Work Authorization is required at time of application
- Ability to report onsite to Gaithersburg, MD 3-5 days a week
Nice To Haves
- Background knowledge of lean principles, user-centered design, and process development preferred
- Medical device knowledge and interest preferred
- Experience or interest in digital/AI/automation and the regulatory field an added plus
- Enthusiasm for collaboration, cross-functional projects, public speaking, and presentation design
Responsibilities
- Help with gathering of data for IVDR (in-vitro diagnostics regulation)/GMO (genetically modified organisms) metrics
- Support an update of GMO regulatory country requirements including research of publicly available information
- Support EUDAMED (European database on Medical Devices) implementation
- Support SDTL (submission delivery team leads) Academy AI agent creation
- Support data validation activities in our digital tool for oncology regulatory approval information
- Help with presentation of regulatory intelligence data analyses using AI tools
- Undertake background literature research for regulatory intelligence queries using publicly available and commercial tools
- Research and analyze regulatory guidance, precedence to support our products and development pipeline
- Assess and improve select existing regulatory processes for medical devices and combination products
- Apply lean principals to understand current process needs, address stakeholder input, implement changes, and propose effectiveness checks
- Re-brand and launch agreed process improvements
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What This Job Offers
Job Type
Full-time
Career Level
Intern
Number of Employees
5,001-10,000 employees
