Intern the Otsuka Way 2026 - GRA/Global Regulatory Operations and Clinical Transparency

Job Summary :

Otsuka’s internship program, Intern the Otsuka Way (InTOW), offers students a unique opportunity to gain hands-on experience and develop critical skills while contributing to meaningful projects. Interns will work alongside experienced professionals, learn about the complexities of the pharmaceutical industry, and gain insights into potential career paths. By combining practical experience with professional development, our program prepares interns for future success. Our internship program also includes instructor led trainings, a leadership engagement series, as well as insightful lunch and learns. 

Interviews and offers: February through March 2026. 

Duration of internship: June 1, 2026, through August 10, 2026.  

Job Description  

The Clinical Transparency Intern will support Clinical Trial Disclosure (CTD) activities related to the registration and results disclosure of OPDC-sponsored clinical trials. This role provides hands-on exposure to a critical regulatory and compliance function, ensuring adherence to requirements under the FDA Amendments Act (FDAAA) and the Final Rule. The intern will gain a deep understanding of how clinical trial transparency protects public trust, supports ethical research conduct, and mitigates regulatory risk, while collaborating across R&D functions and external vendors. By the end of the internship, the intern will: 

• Gain a comprehensive understanding of clinical trial registration and results disclosure processes. 

• Develop practical knowledge of commercially confidential information (CCI) and protected personal data (PPD) principles. 

• Build experience navigating regulatory-driven workflows and compliance timelines. 

• Contribute to efforts that enhance Otsuka’s external reputation as a responsible, transparent, and ethical research organization. 

  Key Responsibilities: 

• Support Clinical Trial Disclosure (CTD) projects, including trial registration, maintenance, and results disclosure on public databases such as ClinicalTrials.gov. 

• Assist with review and quality control of clinical trial records to ensure accuracy, completeness, and regulatory compliance. 

• Collaborate with external vendors and internal cross-functional teams across R&D, Clinical Operations, Data Management, and Medical Affairs. 

• Track and maintain project timelines to meet regulatory disclosure deadlines. 

• Utilize Otsuka’s Clinical Trial Disclosure system (PRIME) to manage disclosure activities and documentation.  

• Support preparation of clinical documents for public disclosure 

• Contribute to the development of educational and training materials for cross-functional subject matter experts involved in registration and results disclosure processes. 

• Identify process inefficiencies within CTD workflows and propose solutions or process improvements. 

Minimum: 

• Graduate student