Manager/Senior Manager, Regulatory Operations - Menlo Park, United States - Corcept Therapeutics

Description

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 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 advance 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.

This position will report to the Director of Regulatory Operations and will be responsible for maintaining the regulatory archives in the Veeva Vault system and the internal shared drive. The Manager/Senior Manager will be working with a diverse team of professionals providing support to various regulatory filings and projects.

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

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience with Veeva Vault systems is preferred
• 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
• 5+ years' experience in the pharmaceutical industry or life sciences with 4+ years of regulatory experience

The pay range that the Company reasonably expects to pay for this headquarters-based position is $145,000 - $205,000; 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:

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.