Veeva Admin. & PRC/MRC Coordinator

Omeros•Seattle, WA

5d•$92,000 - $115,000

About The Position

Omeros is seeking a Veeva Administrator & PRC/MRC Coordinator to join its Marketing team. The position administers and manages Veeva Vault day to day and coordinates the organization’s Promotional Review Committee (PRC) and Medical Review Committee (MRC), ensuring materials, collateral, and documentation comply with applicable guidelines. The role manages Veeva Vault user accounts, permissions, document workflows, system support, training, and process improvement. It coordinates PRC/MRC calendars, meetings, submissions, reviewer discussions, decisions, revisions, and follow-up. The coordinator also maintains review and approval records, supports document and reference management, and helps prepare approved promotional materials for FDA Form 2253 submission. Omeros offers a wage scale of $92,000–$115,000, with salaries determined by relevant knowledge, skills, education, and experience. The position is eligible for incentive compensation and stock options.

Requirements

Bachelor’s degree or equivalent experience required.
Strong project management and organizational skills, including the ability to manage shifting priorities.
Proficiency with Microsoft Office Suite, particularly PowerPoint.
Demonstrated ability to facilitate cross-functional meetings and 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 process-improvement opportunities.
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 is preferred.
Experience supporting or coordinating a PRC or 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 according to established procedures.
Support document workflows, including review, approval, reapproval, expiration, withdrawal, and retirement.
Provide system support and troubleshooting 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 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 discussion and decision-making among Medical, Regulatory, Legal, Compliance, Marketing, and other reviewers.
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 document creation, annotations, references, claims, linking, version control, and workflow functionality.
Create and maintain reference records and supporting documentation in 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.