Director, Medical Writing

The role

The Director, Medical Writing will collaborate with colleagues to write and oversee the development of medical-writing deliverables. This role supports the regulatory requirements of a clinical development program.

What you will do

• Provide Medical Writing leadership in strategic project teams
• Manage in-house medical writing staff, vendors and contractors
• Mentor and support direct reports
• Author, co-author, critically edit, and format clinical/regulatory documents
• Collaborate with document authors, contributors, and reviewers
• 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
• 10+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them)
• Experience managing a team
• 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)

Before you apply

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

About the company

Corcept has been focused on the science of cortisol for more than 25 years. The company is headquartered in Redwood City, California.