Director, Medical Writing at Corcept Therapeutics in Redwood City, CA

Job description

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+ ye