Sr. Regulatory Document Formatting Specialist

Initial Therapeutics, Inc.; San Carlos (CA); Remote; USD 122,000 - 142,000; Full time

Job summary

A leading company in vaccine innovation is seeking a Regulatory Operations professional. The role involves document formatting and quality control for regulatory submissions. Ideal candidates should have extensive experience in document preparation and strong skills in MS Word and Adobe Acrobat Pro. The position is based in San Carlos, CA, with options for remote work, offering competitive compensation and benefits.

Qualifications

• Minimum 7 years industry experience, with at least 2 years in Regulatory Operations.
• Proficiency in MS Word, Adobe Acrobat Pro, PowerPoint, and Excel.

Responsibilities

• Produce high-quality documents within established timeframes.
• Format documents with tables of contents, headers/footers, and multi-page tables using Word.
• Collaborate within an authoring environment (Veeva RIM).

Skills

Attention to Detail

Organizational Skills

Communication

Education

College degree (AA/AS or BA/BS)

Tools

MS Word

Adobe Acrobat Pro

PowerPoint

Excel

Veeva RIM

Job description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases, which have serious health consequences when left unchecked. We aim to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Our path to success is clear, and Vaxcyte is set up to go the distance.

What we do is as important as how we do it! Our work is guided by four core values:

1. Rethink Convention: We bring creative and intellectual diversity to innovate and re-innovate vaccine delivery.
2. Aim High: We aim to make the most complex biologics to protect humankind.
3. Lead with Heart: We foster kindness, inclusivity, and vigorous debate to advance our objectives.
4. Model Excellence: We demonstrate integrity, accountability, and clarity in communication and decision-making.

Summary

This Regulatory Operations role involves formatting and finalizing documents for submissions. Ideal candidates will have experience with complex document formatting, strong skills in Microsoft Word and Adobe Acrobat Pro, and familiarity with document templates. The role supports regulatory submission planning, preparation, and quality control to ensure timely, high-quality filings.

Essential Functions

• Produce high-quality documents within established timeframes.
• Format documents with tables of contents, headers/footers, links, styles, figures, and multi-page tables using Word.
• Collaborate within an authoring environment (Veeva RIM).
• Review documents for consistent formatting according to templates and style guides (abbreviations, citations, hyperlinks, terminology, bibliographies).
• Maintain literature lists for submissions and obtain copies as needed.
• Communicate effectively with Regulatory and other teams to meet deadlines.
• Interact with external publishers to support submission publishing.
• Assist in improving systems, processes, and tools within Regulatory Operations.

Requirements

• Minimum 7 years industry experience, with at least 2 years in Regulatory Operations involving document formatting and word processing.
• College degree (AA/AS or BA/BS) or equivalent experience.
• Proficiency in MS Word, including styles, Track Changes, and comments.
• Proficiency in Adobe Acrobat Pro, PowerPoint, and Excel.
• Excellent attention to detail and organizational skills.
• Ability to work well with others and independently in a fast-paced, regulated environment.
• Familiarity with Veeva RIM and document templates (OmniTemplates is a plus).
• Strong business ethics and confidentiality awareness.

Additional Information

Reports to: Manager, Regulatory Operations

Location: San Carlos, CA; open to remote

Compensation: Competitive, with benefits and equity; Salary Range: $122,000 – $142,000 (SF Bay Area). Ranges may vary for other locations.

We are an equal opportunity employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.