Director, Clinical Medical Writing - Remote

Overview

Vaxcyte is seeking a Director, Clinical Medical Writing to drive and shape the medical writing processes, procedures, strategies, and document generation and maintenance.

In Short

• Lead medical writing activities and manage contract writers.
• Generate key clinical documents for regulatory submissions.
• Develop new SOPs and templates for clinical documents.
• Ensure data quality and compliance with GCP.
• Participate in budget setting and financial management.
• Collaborate across Clinical Operations for quality assurance.
• Champion an inclusive mindset and foster collaboration.
• Identify risks and develop mitigation strategies.
• Manage document generation timelines and budgets.
• Represent Clinical Medical Writing on cross-functional teams.

Requirements

• 12+ years of medical writing experience in clinical research.
• Advanced degree (Ph.D. or PharmD) preferred.
• Experience with major US and international regulatory submissions.
• Strong project management and communication skills.
• Expert-level skills with Microsoft Word and PowerPoint.
• Experience with Veeva Vault and Zoom preferred.
• Ability to travel up to 30% domestically and internationally.
• Strong attention to detail and organizational abilities.
• Proven ability to develop medical writing processes.
• Strong team player who exemplifies core values.

Benefits

• Opportunity to work in a high-growth, fast-paced environment.
• Collaborative and inclusive company culture.
• Engagement in meaningful work to protect humankind.
• Professional development opportunities.
• Competitive salary and benefits package.