Vaxcyte is hiring a
Associate Director Clinical Medical Writing

Summary

Vaxcyte is seeking an Associate Director of Clinical Medical Writing to lead medical writing activities, manage contract writers, and contribute towards a style guide for Vaxcyte. Key responsibilities include generating various clinical documents, participating in cross-functional team discussions, ensuring data quality, managing document generation timelines and budgets, supporting SOP and process development, partnering across Clinical Operations to embed quality and GCP compliance, proactively identifying risks, and championing an inclusive mindset.

Requirements

• Preferred clinical writing experience in clinical vaccine development
• Level commensurate with experience
• Advanced degree (Ph.D. or PharmD) preferred, combined with 10+ years of medical writing experience in the clinical research or biotechnology industry
• Experience as lead writer for key documents included in major US and/or international regulatory submissions required
• Experience managing writing activities for a major US or international regulatory submission (project or people management preferred)
• Strong computer skills, project management skills, and a high attention to detail
• Experience with Zoom and Veeva Vault, preferred
• Strong communication skills (both written and oral)
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
• Expert-level skills w/ Microsoft Word and PowerPoint; and competent with other Microsoft Office 365 apps
• Ability to travel up to 30% domestic and international

Responsibilities

• Lead clinical study documentation including but not limited to clinical protocols, investigator brochures, informed consents, various study plans, and clinical study reports
• Lead cross-functional team discussions to support the development of the above noted clinical trial documents for IND submissions and execution of clinical trials
• Ensure data quality by performing listing reviews per established plans/processes
• Participate in the selection and oversight of vendors contracted for medical writing services
• Manage document generation to finalization timelines and budget; proactively participate in budget setting, forecasting, and other aspects of financial management of the trial (vendor accruals)
• Support SOP and process development and improvement
• Partner across Clinical Operations to embed quality and GCP compliance within day-to-day activities
• Champion an inclusive mindset and approach, and foster collaboration and consistency across studies and programs
• Proactively identify risks and develop and implement mitigation strategies

Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component
• Salary Range: $206,000 – $212,000