Director, Clinical Medical Writer

Summary

Join Vaxcyte, a clinical-stage vaccine innovation company, as their Director, Clinical Medical Writing. This leadership role involves driving medical writing processes, procedures, and strategies, overseeing document generation and maintenance, and managing contract writers and document QC experts. You will lead medical writing activities, generate key documents (protocols, investigator brochures, etc.), provide guidance on regulatory document requirements, and contribute to Vaxcyte's style guide. Success requires strong collaboration, communication, and clinical writing skills within a fast-paced environment. The position includes management responsibilities and opportunities to develop new SOPs and templates. The ideal candidate will be a strong collaborator and communicator, possessing outstanding clinical writing skills and an attitude that fits our culture in a high growth, fast-paced environment.

Requirements

• Experience as lead writer for key documents included in major US and/or international regulatory submissions required
• Proven ability to develop and implement medical writing processes and standards
• Strong computer skills, project management skills, and a high attention to detail
• Strong communication skills (both written and oral)
• Strong organizational abilities and experience in a multitasking environment
• 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
• Strong team player that models our Core Values: is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Responsibilities

• Provide expertise and leadership in the development of regulatory and clinical documents, including the processes and templates that will ensure sustainable and high-quality deliverables
• 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
• Provide strategy and support in the best practices of medical writing for the development organization
• 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
• Represent Clinical Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in BLA/NDA submission planning and documentation
• Champion an inclusive mindset and approach, and foster collaboration and consistency across studies and programs
• Proactively identify risks and develop and implement mitigation strategies
• Will have management responsibilities

Preferred Qualifications

• Preferred clinical writing experience in clinical vaccine development, with Phase I-III and Phase IV post-marketing experience
• Advanced degree (Ph.D. or PharmD) preferred, combined with 12+ years of medical writing experience in the clinical research or biotechnology industry
• Experience managing writing activities for a major US or international regulatory submission (project or people management preferred)
• Experience with Zoom and Veeva Vault, preferred

Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component
• Salary Range: $218,000 – $244,000 (SF Bay Area). Salary ranges for non-California locations may vary