Associate Director - Clinical Medical Writing

September 12

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Vaxcyte

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Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases$1. .$1

51 - 200

Description

• 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.

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. • Models our Core Values: is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.