Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

We are currently seeking a student intern to join our team. The intern will work closely with the Clinical Operations department in the areas of Trial Execution. This role is a paid, hybrid role with some preferred in-office time. Oversight of the role will be managed by subject matter experts within the Clinical Operations Team.

Key Responsibilities: 

• Working with the Clinical Operations team on assigned tasks such as:
  • eTMF and Document Management
    • Perform quality control checks on electronic Trial Master Files
    • Assist in compiling and reviewing essential document packets required to activate new clinical sites
    • Classify and tag uncategorized documents for audit preparedness
    • Provide support and become a key point of contact for contract and budget tracking related activities
  • Site Management and Monitoring Support
    • Assist the clinical trial execution team in monitoring trip report review
    • Assess site and master level Informed Consent documents to ensure compliance with company SOPs
    • Provide team assistance related to assigned Corrective Action Plans activities
  • Process Improvement and Departmental Initiatives
    • Optimize, maintain, and innovate trackers and tools utilized by the clinical operations team
    • Collate documents related to SOPs and training
    • Support ongoing initiatives to gather historical information on study specifics to develop a comprehensive and accurate database
  • Develop an understanding and knowledge of GCP and industry clinical operations standards
  • Preparation of department minutes
  • Collaborate with cross-functional stakeholders as needed

The anticipated hourly rate for this position will be $20.00 to $25.00 per hour.  The actual hourly rate offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.