Note: The job is a remote job and is open to candidates in USA. 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.
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
Skills
- 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.
Company Overview
BioSpace is the leading online community for industry news and careers for life science professionals. It was founded in 1988, and is headquartered in San Francisco, California, USA, with a workforce of 11-50 employees. Its website is http://www.biospace.com/.
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