Executive Director, Medical Writing - Remote

Overview

MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders, utilizing technologies like optogenetics and spatial transcriptomics to develop effective therapies.

In Short

• Establish and oversee medical writing function and resources.
• Lead writing strategy and document organization.
• Independently author or manage preparation of regulatory documents.
• Ensure accuracy and quality of submission-ready documents.
• Coach and develop medical writing team members.
• Conduct literature searches and manage clinical trial disclosures.
• Develop document templates and quality control checklists.
• Maintain relevant SOPs and internal best practices.
• React rapidly to changing environments and recommend improvements.
• Willingness to travel for team meetings.

Requirements

• Bachelor's degree with significant relevant writing experience.
• Advanced degree preferred (MS, PharmD, PhD, MD).
• AMWA certification or similar preferred.
• 10 years of medical/regulatory writing experience in pharmaceuticals.
• 5 years of regulatory document project management experience.
• Extensive knowledge of English grammar and AMA style guide.
• Experience mentoring and managing medical writers.
• Track record of successful regulatory filings.
• Knowledge of drug development and clinical research.
• Understanding of US and international regulatory requirements.

Benefits

• Equal opportunity employer with a commitment to diversity.