For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.

This position will collaborate with colleagues to write and/or oversee the development of high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements

Responsibilities

Provide Medical Writing leadership in strategic project teams as the medical writing subject matter expert, including advising such teams on content, format, and style requirements for documents
Manage in-house medical writing staff, vendors and contractors, providing guidance on prioritization, content, timeline development, and process management
Mentor and support direct reports in the development of their skills and careers
Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, and other regulatory submissions as needed
Collaborate with document authors, contributors, and reviewers to deliver on clinical documents, including effective communication to manage expectations, resolve issues, and ensure alignment on document timelines and content
Lead the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables
Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines

Preferred Skills, Qualifications and Technical Proficiencies

Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines
Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness
Successful track record of working on complex clinical/regulatory writing projects across multiple therapeutic areas
Excellent attention to detail, multitasking, prioritization, and flexibility
Excellent communication skills with proven ability to interact in a cross-functional environment
Understanding of the drug-development process, including research and development processes and objectives and the required documents
Familiarity with US and European regulatory requirements and guidelines for documents; general knowledge of electronic Common Technical Document (e-CTD) requirements with respect to structure, format, and content
Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
Proficiency in use of MS Office applications (Word, Outlook, Excel, Powerpoint), Adobe Acrobat, electronic document management systems (eg, Veeva Vault, Box, SharePoint), and templates (eg, StartingPoint).
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision

Preferred Education and Experience

BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
10+ years (Director) of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience managing a team and writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents