Corcept is engaged in the discovery and development of drugs that treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity.
In addition to our commercial product, Korlym, we have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators. Lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer, weight gain caused by antipsychotic medications and non-alcoholic steatohepatitis (“NASH”). We are about to start a Phase 2 trial in patients with amyotrophic lateral sclerosis (“ALS”).
In 2021, we generated revenue of $366 million and net income of $112 million.
The Quality Control and Editorial Specialist, Medical Writing and Publications position will support the development of high-quality documents (clinical regulatory documents and publications) for the Medical Writing and Publications groups within the Clinical Development team. They will also rigorously confirm the accuracy of data and text relative to validated data source files, particularly clinical data
- Perform a quality check (QC) of clinical regulatory documents and publications prior to their approval: proofread documents for grammatical errors, formatting errors, hyperlink and bookmark functionality (as appropriate); perform data verification, cross-referencing, fact-checking, and general quality assessments of documents. Clinical regulatory documents may include clinical study reports, clinical study protocols and amendments, Investigator’s Brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs), and other regulatory submission documents. Publications may include manuscripts and congress abstracts and presentations (posters and slides for oral presentations)
- Ensure documents comply with company and/or industry style guides and templates, and consistency within a document and across related documents
- Work collaboratively with internal and external medical writers, regulatory publishers, and project team members to deliver high-quality documents in a timely manner
- Manage QC/editorial timelines and communicate with other members of the Medical Writing and Publications groups and stakeholders outside of the Medical Writing and Publications groups to maintain awareness of expectations, milestones, and deliverables
- Maintain records/archive for completed documents
- May manage QC specialist contractors, as needed
- Develop, enhance, and implement policies, procedures, and processes necessary to achieve organizational objectives and ensure compliance with Corcept and external (e.g., government, institutional) regulations
- Perform miscellaneous job-related duties and additional duties and responsibilities as needed
Preferred Skills, Qualifications and Technical Proficiencies:
- Proven ability to communicate in clear, concise English in both written and oral forms
- Able to prioritize tasks, work simultaneously on multiple projects and complete high-quality documents according to tight timelines and shifting priorities and business needs
- Strong attention to detail, for maintenance of consistency, grammar, syntax, logical flow, and scientific accuracy (fact-checking)
- Familiarity with American Medical Association (AMA) style
- Strong proficiency with Microsoft Office (Word, Outlook, Excel, Powerpoint). EndNote, and Adobe Acrobat
- Familiarity with electronic document management systems (eg, Veeva Vault, Box, Sharepoint)
- Able to work independently and collaboratively, as needed
Preferred Education and Experience:
- 1–3 years of relevant industry experience as a QC editor/specialist, medical writer or copyeditor
- Knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and other relevant regulatory rules and guidelines
- Solid understanding of clinical research, including clinical trial/drug development, medical terminology
Applicants must be currently authorized to work in the United States on a full-time basis.
If you are based in California, we encourage you to read this important information for California residents linked here.
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