Global Medical Affairs Oncology Governance Intern at DAIICHI SANKYO INC

Basking Ridge, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Mar, 26

Salary

58.15

Posted On

07 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

FDA Regulations, ICH Regulations, Health Authority Regulations, Compliance, Writing Processes, Clinical Trial Development, Clinical Trial Operations, Investigation, Root Cause Analysis, Document Review, SOP Review, CAPA Planning, Action Resolution, Summary Findings, Protocol Review, Gaps Identification

Industry

Pharmaceutical Manufacturing

Description

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. We are currently seeking a Global Medical Affairs Oncology Governance Intern for Summer 2026. This full-time position works approximately 37.5 hours per week. Responsibilities: Track timelines for CAPA actions Assist in Investigations to determine RCA Obtain documents necessary for investigation Review key documents and provide summary of findings Meet with key personnel involved in CAPA planning and action resolution Review SOPs and provide summary of any gaps and processes not being followed Provide support in the protocol review committee Qualifications: Basic understanding of FDA, ICH regulations, Interest in learning about health authority regulations and compliance. Knowledge about writing processes and procedures. Basic understanding of clinical trial development and operations Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $17.23 - $58.15 Download Our Benefits Summary PDF At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.

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Responsibilities

The intern will track timelines for CAPA actions and assist in investigations to determine root cause analysis. They will also review key documents and meet with personnel involved in CAPA planning and action resolution.