Offer summary

Qualifications:

Minimum 8 years of industry experience, with at least 2 years in Regulatory Operations., College degree (AA/AS or BA/BS) or equivalent experience., Comprehensive knowledge of MS Word formatting and document assembly., Proficient in Adobe Acrobat Pro, PowerPoint, and Excel..

Key responsabilities:

Format and finalize documents for regulatory submissions.

Ensure consistency in document formatting according to internal templates and style guides.

Communicate effectively with the Regulatory team and other functional groups to meet project timelines.

Assist in implementing and improving systems, processes, and tools within Regulatory Operations.

Job description

Join our Mission to Protect Humankind!

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

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

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. This role will assist with regulatory submission planning, preparation, and QC to ensure high quality, timely submission of regulatory filings to health authorities.

Essential Functions:

Ideal candidates should be able to 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.

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. Other combinations of education and/or experience may be considered.

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.

Familiarity with Veeva RIM is a plus.

Experience using document templates; familiarity with OmniTemplates a plus.

Sound business ethics, including the protection of proprietary and confidential information, is required.

Reports to: Manager, Regulatory Operations

Location: San Carlos, CA; Open to remote

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $122,000 – $142,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Vaxcyte, Inc.

825 Industrial Road, Suite 300

San Carlos, CA 94070

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Required profile