Hybrid Sr Associate, Regulatory Operations bei Corcept therapeutics
Corcept therapeutics · Redwood City, California, Vereinigte Staaten Von Amerika · Hybrid
- Optionales Büro in Redwood City, California
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
The Sr Associate, Regulatory Operations will report to the Director of Regulatory Operations and will support various regulatory activities. The Sr. Associate will work with members of the Regulatory group, other departments, and vendors to manage regulatory requirements and submissions. This is a hybrid role typically requiring on-site presence at least 3 days per week.
Responsibilities:
- Assisting Regulatory Operations members with maintaining the Veeva Vault RIM system and ensuring that all regulatory records are up to date
- Supporting the GxP change control processes in Veeva Vault
- Supporting the QC of regulatory documents prior to submission to health authorities
- Collaborate with the publishing vendor for e-submission files and submission receipts
- Managing the spreadsheet with all weekly/monthly regulatory submissions and communicating the information with the publishing vendor
- Maintaining templates and style guides for regulatory submissions
- Supporting regulatory contract finalization through Corcept’s online contract management platform
- Participating in the development of Standard Operating Procedures (SOPs)
- Managing the preparation and submission of IND/NDA annual reports to health authorities
- Supporting Regulatory team members with regulatory filings and projects, as needed
Preferred Skills, Qualifications and Technical Proficiencies:
- 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
Preferred Education and Experience:
- BA/BS degree in a scientific discipline
- 3+ years of relevant regulatory experience in the pharmaceutical industry
- Experience with publishing and Veeva Vault systems is preferred
The pay range that the Company reasonably expects to pay for this headquarters-based position is $121,300 - $142,800 ; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
