Senior Regulatory Document Formatting Specialist

Summary

Join Vaxcyte, a clinical-stage vaccine innovation company, as a Regulatory Operations specialist! This role focuses on formatting and finalizing documents for regulatory submissions. You will utilize your expertise in Microsoft Word and Adobe Acrobat Pro to ensure high-quality, timely submissions. The ideal candidate possesses at least 8 years of industry experience, including 2 years in Regulatory Operations, and a strong understanding of document formatting. This position offers a competitive compensation package, including comprehensive benefits and an equity component. The location is San Carlos, CA, with remote options considered. Vaxcyte values collaboration, innovation, and excellence.

Requirements

• Minimum 8 years of industry experience and at least 2 years of Regulatory Operations with formatting/word processing documents for regulatory submissions preferred
• College degree, AA/AS or BA/BS
• Comprehensive knowledge of formatting and document assembly using MS Word including Track Changes and Comments functions and document styles
• Proficient with Adobe Acrobat Pro, PowerPoint, and Excel
• Excellent attention to detail and organizational/time-management skills
• Must work well with others
• Must be accountable, adaptable, and dependable
• Accustomed to fast-paced, highly regulated environment with the ability to work independently
• Sound business ethics, including the protection of proprietary and confidential information, is required

Responsibilities

• Produce high quality documents within established time frames
• Use Word to format documents that include tables of contents, headers and footers, links, styles, figures, and multiple-page tables
• Work in a collaborative authoring environment (Veeva RIM)
• Review documents to ensure that formatting is consistent throughout documents in accordance with internal templates and style guide (use of abbreviations, in-text citations, hyperlinks, terminology, bibliographies, etc.)
• Maintain the list of literature for regulatory submissions and obtaining copies of literature, as needed
• Communicate effectively with the Regulatory team and other functional groups, as needed, to meet project timelines
• Interact with the external publisher to support publishing of regulatory submissions
• Assist with Regulatory Operations efforts to implement and improve systems, processes, and/or tools

Preferred Qualifications

• Familiarity with Veeva RIM is a plus
• Experience using document templates; familiarity with OmniTemplates a plus

Benefits

• Competitive compensation package
• Comprehensive benefits
• Equity component
• Salary Range: $122,000 – $142,000 (SF Bay Area)
• Remote work option