Senior Regulatory Document Formatting Specialist

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The company focuses on eradicating or treating infections such as invasive pneumococcal disease, Group A Strep, and Shigella.

Responsibilities

• Format and compile documents using Microsoft Word to create tables of contents, headers/footers, and figure titles
• Use track changes, comment functions, bookmarks, and links to finalize regulatory documents
• Work within a collaborative authoring environment using Veeva RIM
• Review documents for consistency in accordance with internal templates and style guides
• Maintain literature lists for regulatory submissions and obtain necessary copies
• Communicate with Regulatory and functional teams to meet project timelines
• Assist in implementing and improving Regulatory Operations systems, processes, and tools

Requirements

• College degree (AA/AS or BA/BS) with minimum 5 years of experience in Regulatory Operations
• Proficiency in Microsoft Word, Adobe Acrobat Pro, PowerPoint, and Excel
• Understanding of CTD structure and Clinical documents (Protocols, CSRs, SAPs, etc.)
• Ability to work independently in a fast-paced, highly regulated environment
• Excellent attention to detail and organizational skills

Preferred Qualifications

• Experience using Veeva RIM for authoring and reviewing documents
• Experience with OmniTemplates