Regulatory Affairs Intern
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Job Description
About Corcept Therapeutics:
Corcept Therapeutics is a biopharmaceutical company focused on the research and development of cortisol modulators. They have discovered over 1,000 proprietary cortisol modulators and received FDA approval for Korlym® (mifepristone) in 2012, the first approved treatment for Cushing’s syndrome. The company is currently conducting over 30 studies across various disease areas including endocrinology, oncology, metabolism, and neurology. Corcept is a fast-growing biotech company located in the Bay Area. They are committed to high ethical and technical standards throughout their operations, encompassing development, manufacturing, clinical research, and commercial activities.
Job Description: Regulatory Affairs Internship
Corcept’s Regulatory Affairs (RA) department is seeking interns to contribute to their mission of revolutionizing the treatment of serious diseases through cortisol modulation. The internship is a full-time (40 hours/week) position lasting at least 10 consecutive weeks between June and August, requiring on-site work at their Redwood City, CA office (no relocation assistance provided).
Responsibilities:
Interns will participate in a variety of projects, including:
• Regulatory Document Review and Organization: Reviewing, organizing, and summarizing complex information and documentation supporting regulatory activities for both existing and new products.
• Regulatory Filing Support: Contributing to the preparation of regulatory filings for new product approvals.
• Shadowing RA Team Members: Observing and learning from RA team members by attending meetings, ranging from routine updates to high-level strategy sessions.
• Department Presentation: Delivering a presentation to the department at the end of the internship program.
• Team Project: Participating in a group project with other interns, culminating in a company-wide presentation.
Preferred Skills and Qualifications:
• Exceptional interpersonal skills and a proven ability to work effectively in teams.
• Strong organizational skills and the ability to manage multiple tasks efficiently.
• Problem-solving skills: Ability to quickly identify problems and develop effective solutions.
• Excellent communication skills: Proficiency in written, verbal, and presentation formats.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, SharePoint) and Smartsheet.
• Passion for a career in biotech, pharmaceuticals, or the life sciences.
Preferred Education and Experience:
Currently pursuing an associate’s or bachelor’s degree.
Compensation:
The expected pay range is $25/hr – $31/hr, but the final offer may vary based on factors such as location, skills, experience, and education. Applicants must be authorized to work in the US on a full-time basis.
