Veeva Admin. & PRC/MRC Coordinator

Omeros • Seattle, WA

5d

About The Position

Omeros is seeking a Veeva Administrator & PRC/MRC Coordinator to join its Marketing team. The role administers and manages Veeva Vault day to day and coordinates the organization’s Promotional Review Committee (PRC) and Medical Review Committee (MRC), helping ensure materials, collateral, and documentation comply with established guidelines.

The position provides operational support for Veeva Vault, including user access, document workflows, troubleshooting, user training, process monitoring, and system improvements. It coordinates PRC/MRC meetings and review calendars; checks submission materials for completeness; documents decisions, revisions, and follow-up; and tracks materials through review and approval. The coordinator also supports document and reference management in Vault and coordinates preparation and timely submission of approved promotional materials for FDA Form 2253.

Omeros is a biotechnology company that discovers and develops protein and small-molecule therapeutics for large-market and orphan indications. Its work focuses on complement-mediated diseases, cancers, and addictive or compulsive disorders.

Requirements

• Bachelor’s degree or equivalent experience required.
• Strong project management and organizational skills, with the ability to manage shifting priorities.
• Proficiency with Microsoft Office Suite, particularly PowerPoint.
• Demonstrated ability to facilitate cross-functional meetings and drive follow-up on decisions and action items.
• Strong interpersonal skills and ability to work effectively with Marketing, Medical Affairs, Regulatory, Legal, Compliance, agencies, vendors, and senior stakeholders.
• Collaborative, proactive approach with a strong customer-service mindset.
• Strong problem-solving skills and ability to identify opportunities for process improvement.
• Ability to train and support users with varying levels of technical and Veeva experience.
• Exceptional attention to detail and commitment to accurate documentation.
• Ability to understand and apply established procedures within a regulated environment.
• Strong written and verbal communication skills.

Nice To Haves

• 3–5 years of experience in the biotech, pharmaceutical, or healthcare-related industry.
• Experience with Veeva Vault or a similar system.
• System administrator experience.
• Experience supporting or coordinating a Promotional Review Committee (PRC) or Medical Review Committee (MRC) review process.
• Experience with pharmaceutical promotional material development, review, approval, and lifecycle management.
• Familiarity with FDA promotional requirements and Form FDA 2253 processes.
• Experience with project management or CRM tools.

Responsibilities

• Serve as the primary day-to-day administrator and operational resource for Veeva Vault.
• Create and maintain user accounts and permissions in accordance with established procedures.
• Support document workflows, including review, approval, reapproval, expiration, withdrawal, and retirement.
• Provide system support and troubleshooting assistance to material owners, reviewers, agencies, and other users.
• Train and onboard new users, reviewers, coordinators, and designated delegates.
• Monitor system processes and workflows and identify opportunities to improve efficiency, consistency, and user experience.
• Coordinate and facilitate PRC/MRC meetings, including scheduling, logistics, agendas, reviewer availability, and material prioritization.
• Maintain the PRC/MRC review calendar and communicate submission deadlines, meeting schedules, and process requirements.
• Review materials before PRC/MRC review to confirm required documentation, references, annotations, and supporting materials are complete and accurate.
• Prepare and distribute meeting agendas and identify materials requiring discussion, priority review, or follow-up.
• Facilitate PRC/MRC meetings and support efficient discussion and decision-making among reviewers and stakeholders.
• Document review decisions, required revisions, action items, and next steps.
• Track materials through the review and approval process and follow up on outstanding actions or potential delays.
• Coordinate with material owners and agencies to ensure reviewer comments and required revisions are addressed.
• Guide stakeholders on established PRC/MRC processes, submission requirements, and material workflow expectations.
• Maintain accurate documentation of PRC/MRC decisions and approval history.
• Support users with document creation, annotations, references, claims, linking, version control, and workflow functionality.
• Create and maintain reference records and supporting documentation within Veeva Vault.
• Support preparation and coordination of approved promotional materials for FDA Form 2253 submission.
• Coordinate with Regulatory and designated submitters to facilitate timely submission of promotional materials.

Benefits

• Medical, dental, vision, and life insurance.
• 401(k) plan with company match.
• Three weeks of vacation accrued annually.
• 80 hours of sick time accrued annually.
• Twelve paid holidays throughout the calendar year.
• Eligibility for incentive compensation and stock options.

What This Job Offers

• Job Type: Full-time