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:
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte as a Senior Clinical Document Specialist within the Regulatory department. The primary function of this role is to support the electronic Trial Master File (eTMF) team for all products in development and to collaborate with internal and external contributors to the eTMF.
Essential Functions:
- Perform Quality Control (QC) activities within Veeva Vault eTMF in compliance with established processes.
- Serve as a member of the TMF Operations team, managing the TMF support mailbox, triaging TMF-related inquiries, and assigning tasks to appropriate team members.
- Contribute to the development of study-specific TMF Plans and TMF Indices, ensuring alignment across departments.
- Support global TMF health activities, including generating and analyzing TMF metrics, identifying trends, and escalating issues as necessary.
- Participate in system change control activities, such as User Acceptance Testing (UAT), to support system updates and improvements.
- Develop and maintain training materials, Quick Reference Guides, Standard Operating Procedures (SOPs), and Work Instructions (WIs) to ensure consistency and clarity in TMF processes.
- Assist in the delivery of high-quality eTMF system training and documentation for team members and stakeholders.
- Drive process improvement initiatives for TMF operations to enhance efficiency and compliance.
- Act as an eTMF subject matter expert (SME) during audits and provide support for audit responses.
- Collaborate on training programs to address process gaps and enhance team proficiency in eTMF operations.
- Support other TMF-related responsibilities and projects as required.
Requirements:
- BA/BS degree in life sciences with a minimum of 8 years of experience in the pharmaceutical or biotechnology industry. Other combinations of education and/or experience may be considered.
- Must have industry experience managing or supporting TMF initiatives, preferably in a Sponsor or CRO environment.
- Veeva Vault eTMF experience is required.
- Strong communication skills and the ability to collaborate across teams.
- Flexible and adaptable to a fast-paced, dynamic environment.
- Excellent time management and organizational skills.
- Proficient with Microsoft Office Suite and SharePoint.
- Familiarity with clinical trial documentation and regulatory requirements across all phases of drug development.
Reports to: Director, Regulatory Operations and Compliance
Location: San Carlos, CA; Open to remote
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $112,000 – $131,000 (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.
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Last updated on Feb 11, 2025