Job Description

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice ( and Terms of Use ( . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** Global Development Compliance ensures quality and compliance in Clinical Development in partnership with R&D Quality and GCP Functions. We champion continuous improvement, foster innovation, and maintain an efficient, inspection-ready clinical development model. Embracing technology and automation, we aim to enhance efficiency, streamline processes, and accelerate the delivery of medicines to patients. As GDC Intern, you will have the opportunity to contribute to focused projects for Takeda's R&D and GCP Functions that help drive efficiency, streamline processes, and accelerate the ways we work. Key responsibilities may include: GCP Continuous Improvement Projects: + 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. GCP Excellence in Clinical Trials Projects: + 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 **How You Will Contribute:** As a Global Development Compliance Intern, you will have the opportunity to... + 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. + Demonstrate a proven record of accomplishment of teamwork, adaptability, innovation, initiative, and integrity. **Internship Development Opportunities:** + Gain understanding of Good Clinical Practice (GCP) and experience working within a Clinical Trial Delivery environment. + Gain experience with conduct of clinical trials (phases 1-4). + Gain knowledge of regulatory requirements governing clinical trials and industry best practices. + Hone exceptional interpersonal, verbal communication and writing skills. + Learn more about Clinical Trial Delivery, Good Clinical Practice and bringing medicine to patients. + Learn how to have a global mindset to grow in a diverse work environment. + Learn how to collaborate with and work within cross-functional teams. **Job Requirements:** + 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. + This position will be Fully Remote out of the Cambridge, MA location. + Must be pursuing a Bachelor's, Masters, or Doctoral degree in a scientific, business, or relevant discipline. **Internship Eligibility**   + 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  + The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)   + The intern must be able to commit to one of these time frames   + Able to work full time 40 hours a week during internship dates   + Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program  ** ** **Program Highlights:**   + Hands-on experience with real projects and responsibilities  + Dedicated mentorship program pairing interns with experienced professionals  + Networking opportunities with industry professionals and fellow interns  + Internship events focused on professional and skills development   + Exposure to multiple business areas or departments within a Pharmaceutical Organization  Applications will be accepted between November 7th - November 30th **Takeda Compensation and Benefits** **Summary** We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** Florida - Virtual **U.S. Hourly Wage Range:** $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: + 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. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Florida - Virtual **Worker Type** Employee **Worker Sub-Type** Paid Intern (Fixed Term) (Trainee) **Time Type** Full time **Job Exempt** No \#LI-Remote

Job Tags

Hourly pay, Minimum wage, Permanent employment, Full time, Fixed term contract, Traineeship, Summer internship, Work at office, Local area, Remote work, Relocation package,

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