What are the responsibilities and job description for the Intern - Regulatory position at Cytokinetics?
At Cytokinetics we are dedicated to supporting the next generation of biotech professionals through our annual Cytokinetics Internship Program. We believe that investing in enthusiastic students and recent graduates brings fresh perspectives and insights to our teams and we take pride in providing opportunities to contribute to meaningful projects. Through our Internship Program we aim to provide a challenging and rewarding experience to build a strong foundation for a career in the biopharmaceutical industry.
This is a paid internship at our South San Francisco headquarters. The program is for approximately 12 weeks beginning in late May/early June.
Job Description:
The summer intern working in the Regulatory Affairs department will:
- Develop an understanding of the structure of and roles within a biopharmaceutical company and of the drug development process
- Support the development of tools to enhance clinical process training and compliance
- Assist with regulatory intelligence activities, including research, presentations, and development of communications tools
- Develop regulatory skills required to assist in supporting clinical trial conduct and therapeutic program activities, including regulatory submissions and responses to health authority queries as needed
- Support the maintenance of regulatory files and documentation to ensure compliance
- Assist with development of new interdisciplinary processes
- Gain cross-functional exposure to Regulatory CMC, Regulatory Advertising and Promotion, Regulatory Labeling, Regulatory Operations, Quality, and other functional areas
- Assist with ongoing regulatory projects
- Along with other Cytokinetics’ summer interns, showcase your work through a presentation to the organization
Requirements:
- Currently enrolled undergraduate or graduate student or recent graduate with a major in science, engineering, or related field
- Basic knowledge of healthcare industry and strong passion for biotech
- Extremely organized, detail oriented and resourceful
- Proficient in Microsoft programs including Outlook, Word, Excel, and PowerPoint
