Director, Medical Writing

Corcept Therapeutics•Redwood City, CA

3d•$183,500 - $242,800•Onsite

About The Position

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.

Requirements

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
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

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