Sr. Regulatory Document Formatting Specialist - Remote

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.