Associate Director, Medical Writing

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 Associate Director, Medical Writing will collaborate with colleagues to write 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:

• 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, administrative letters, and other regulatory submissions as needed
• Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
• Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
• Facilitate comment resolution and adjudication with authors, reviewers, and project teams
• Oversee vendors and contractors
• May include management of in-house medical writing staff (based on experience and team need)
• Serve as the functional area representative on project teams and advise such teams on content, format, and style requirements for documents
• 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
• Interview, mentor, and assist in the integration of medical writing staff as needed
• 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
• 8+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications