Associate Director, Medical Writing

The role

This person will author, edit, and format clinical and regulatory documents to support clinical development programs. They will collaborate with cross-functional teams to ensure documents meet US and ex-US regulatory requirements.

What you will do

• Author, co-author, critically edit, and format clinical/regulatory documents
• Interact with document authors, contributors, and reviewers to acquire necessary input
• Develop and manage medical writing timelines
• Lead comment resolution and adjudication with authors, reviewers, and project teams
• Oversee vendors and contractors
• May include management of in-house medical writing staff
• Serve as the functional area representative on project teams
• Lead the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control
• Maintain subject area expertise related to investigational products, disease indications, and regulatory and publication guidelines

Required qualifications

• BA/BS degree in a scientific field
• 7+ years of regulatory medical writing experience in the pharmaceutical industry or an organization serving them
• Experience writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs)
• Understanding of the content of higher-level summary documents

Nice to have

• Advanced scientific degree (PhD, PharmD, or MS)
• 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,
• 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, StartingPo

Before you apply

• Applicants must be currently authorized to work in the United States on a full-time basis

About the company

Corcept is focused on the science of cortisol to address diseases. The company is headquartered in Redwood City, California.