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BioSpace · 1 month ago

2026 Summer Internship Program: Global Development Compliance Intern

United States

Internship

Remote

Intern

$21/hr - $46/hr

Start in 2026 Summer

BioSpace is a company focused on global development compliance in clinical trials. As a Global Development Compliance Intern, you will support projects aimed at enhancing efficiency and compliance in clinical development processes, while gaining valuable experience in Good Clinical Practice and clinical trial delivery.

BiotechnologyCommunitiesHealth CareMedical

Comp. & Benefits

No H1B

Responsibilities

Support overall development of new or revised Good Clinical Practice (GCP) and Clinical Trial Delivery processes and/or training content (may include supporting process map development and refinement, SOPs, RACIs, and developing training content)

Support translation of process maps into Takeda systems

Help prepare for, facilitate and support project workshops with key subject matter experts (SMEs)

Partner with stakeholders and key SMEs to update and/or create documentation and/or training content

Initiate and facilitate review and feedback for GCP SOPs, process maps, and/or training content

Provide weekly status updates to project teams and manage project plans and action/decision logs

Contribute to GCP inspection readiness, strategy, and execution activities

Coordinate key activities to enable study team readiness for internal audits and regulatory inspections

Collaborate with the study execution teams on inspection readiness projects

Support real-time regulatory inspections and audits

Contribute to Trial Master File (TMF) health improvement efforts and review key essential trial documentation

Identify and implement improvements in inspection readiness and study execution processes

Pilot innovative technologies and automations for Trial Master File oversight

Support and lead aspects of important cross-functional projects at Takeda

Work on deadline-driven activities with an elevated level of organizational and planning skills

Practice strong quantitative, analytical, problem solving and presentation skills

Practice cross functional teamwork and collaboration with key stakeholders

Qualification

Clinical Practice (GCP)Clinical Trial DeliveryProject management toolsMicrosoft OfficeAnalytical skillsEffective communicationTeamworkProblem-solvingAttention to detail

Required

Must be pursuing a Bachelor's, Masters, or Doctoral degree in a scientific, business, or relevant discipline

Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship

Must be currently enrolled in a degree program graduating December 2026 or later

Able to work full time 40 hours a week during internship dates

Adept at utilizing computer software programs (e.g., Microsoft Office and Excel) and project management and collaboration tools (e.g., SharePoint, Teams) to efficiently organize and execute projects

Strong problem-solving abilities and attention to detail

Effective communication skills and ability to influence stakeholder engagement

Ability to work in a fast-paced environment and prioritize tasks

Benefits

Paid sick time

Civic Duty paid time off

Participation at company volunteer events

Participation at company sponsored special events

Access to on-site fitness center (where available)

Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.