Full-Time
Manager/Senior Manager
Posted on 4/18/2024
Develops cortisol modulation technologies for diseases
Biotechnology
Compensation Overview
$145,000 - $205,000Annually
Senior
Menlo Park, CA, USA
Required Skills
Communications
Word/Pages/Docs
PowerPoint/Keynote/Slides
Requirements
- Experience with Veeva Vault systems
- Detail oriented with excellent oral and written communication skills
- Strong team player, self-motivated and able to function independently as well as part of a team
- Able to work on multiple projects concurrently and adapt to a continuously changing environment
- Proficient in organization, prioritization, and time management
- Experience with Microsoft Word, PowerPoint and Excel
- BA/BS degree in a scientific discipline
- 5+ years' experience in the pharmaceutical industry or life sciences with 4+ years of regulatory experience
Responsibilities
- Maintaining the Veeva Vault RIM system and ensuring that all regulatory records are up to date
- Managing the change control process in Veeva Vault RIM
- Maintaining the Regulatory shared drive and ensuring that all US/ex-US submissions and correspondence files are up to date
- Collaborating with the external publishing vendor for e-submission files and submission receipts
- Managing the spreadsheet that lists all weekly/monthly regulatory submissions and communicates the information with the external publishing vendor
- Maintaining templates and style guides for regulatory submissions
- Working closely with other members of the Regulatory team and provide support to their projects as needed
- Participating in the development of standard operating procedures
Corcept Therapeutics specializes in developing selective glucocorticoid receptor antagonists to address the adverse effects of excess cortisol in a range of diseases, with a primary emphasis on creating a new generation of compounds aimed at mitigating the effects of excess cortisol in various diseases. Their focus is on cortisol modulation technologies for endocrine, metabolic, oncologic, and psychiatric disorders, with a pipeline of over 30 ongoing studies.
Company Stage
IPO
Total Funding
$119.1M
Headquarters
Menlo Park, California
Founded
1998
Growth & Insights
Headcount