Remote Otter LogoRemoteOtter

Sr. Regulatory Document Formatting Specialist - Remote

Posted 1 week ago
All others
Full Time
CA, USA

Overview

This role in Regulatory Operations will format and finalize documents for regulatory submissions. Ideal candidates will have experience formatting complex documents, in-depth understanding of Microsoft Word and Adobe Acrobat Pro, and familiarity with using document templates.

In Short

  • 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 for consistent formatting according to internal templates and style guide.
  • Maintain the list of literature for regulatory submissions.
  • Communicate effectively with the Regulatory team and other functional groups.
  • 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.

Requirements

  • Minimum 8 years of industry experience and at least 2 years in Regulatory Operations.
  • Comprehensive knowledge of formatting and document assembly using MS Word.
  • Proficient with Adobe Acrobat Pro, PowerPoint, and Excel.
  • Excellent attention to detail and organizational/time-management skills.
  • Must work well with others and be accountable, adaptable, and dependable.
  • Accustomed to fast-paced, highly regulated environment.
  • Familiarity with Veeva RIM is a plus.
  • Experience using document templates; familiarity with OmniTemplates a plus.
  • Sound business ethics required.

Benefits

  • Opportunity to work in a mission-driven company.
  • Collaborative work environment.
  • Engagement in innovative vaccine development.
Vaxcyte logo

Vaxcyte

Vaxcyte is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at protecting humankind from serious bacterial diseases. With a focus on eradicating or treating infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella, Vaxcyte is committed to addressing the significant health consequences of these conditions. The company operates under four core values: rethinking convention, aiming high, leading with heart, and modeling excellence, which guide their collaborative and innovative approach to vaccine development. Vaxcyte is positioned for success in the biotechnology sector, emphasizing quality assurance and regulatory compliance in its operations.

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