Veeva Administrator & PRC/MRC Coordinator

Veeva Administrator & PRC/MRC Coordinator

We are a fast-growing and dynamic organization seeking a Veeva Administrator & PRC/MRC Coordinator to join our Marketing team. This position is responsible for the administration and day-to-day management of Veeva Vault and for coordinating the organization’s Promotional Review Committee (PRC), and Medical Review Committee (MRC).  Ensures that materials, collateral and documentation are within compliance guidelines.

Good things are happening at Omeros!

Who is Omeros?

Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA^® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.

Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs, visit www.omeros.com.

What are your job responsibilities?

Your responsibilities in this position will include:

Veeva Vault Administration

• Serves as the primary day-to-day administrator and operational resource for Veeva Vault.
• Creates and maintains user accounts and permissions in accordance with established procedures.  Support document workflows, including review, approval, reapproval, expiration, withdrawal, and retirement.
• Provides ongoing system support and troubleshooting assistance to material owners, reviewers, agencies, and other users.
• Trains and onboard new users, reviewers, coordinators, and designated delegates.
• Monitors system processes and workflows and identify opportunities to improve efficiency, consistency, and the user experience.

PRC/MRC Coordination

• Coordinates and facilitate PRC/MRC meetings, including scheduling, meeting logistics, agendas, reviewer availability, and material prioritization.
• Maintains the PRC/MRC review calendar and communicate submission deadlines, meeting schedules, and process requirements to stakeholders.
• Reviews materials prior to PRC/MRC review to confirm required documentation, references, annotations, and supporting materials are complete and accurate.
• Prepares and distribute meeting agendas and identify materials requiring discussion, priority review, or follow-up.
• Facilitates PRC/MRC meetings and supports efficient discussion and decision-making among Medical, Regulatory, Legal, Compliance, Marketing, and other reviewers.
• Documents review decisions, required revisions, action items, and next steps.
• Tracks materials throughout the review and approval process and proactively follow up on outstanding actions or potential delays.
• Coordinates with material owners and agencies to ensure reviewer comments and required revisions are addressed.
• Provides guidance to stakeholders regarding established PRC/MRC processes, submission requirements, and material workflow expectations.
• Maintains accurate documentation of PRC/MRC decisions and approval history.
• Supports users with document creation, annotations, references, claims, linking, version control, and workflow functionality.
• Creates and maintains reference records and supporting documentation within Veeva Vault.
• Supports the preparation and coordination of approved promotional materials for FDA Form 2253 submission.
• Coordinates with Regulatory, and designated submitters to facilitate timely submission of promotional materials.

What education and experience do you need?

• Bachelor’s degree or equivalent experience required.
• Minimum of 3-5 years of experience in biotech, pharmaceutical, or healthcare-related industry preferred.
• Experience with Veeva Vault, or similar system is strongly preferred.  System administrator experience preferred.
• Experience supporting or coordinating a Promotional Review Committee (PRC), or Medical Review Committee (MRC) review process preferred.
• Experience with pharmaceutical promotional material development, review, approval, and lifecycle management preferred.
• Familiarity with FDA promotional requirements and Form FDA 2253 processes preferred.
• Strong project management and organizational skills; ability to manage shifting priorities.
• Proficiency with Microsoft Office Suite, particularly PowerPoint; experience with project management or CRM tools is a plus.

What We’re Looking for in an Ideal Candidate:

• 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.

Compensation and Benefits:

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for this position is ($92,000 - $115,000). Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for incentive and stock options. To learn more about Omeros, please visit www.omeros.com. 

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can send an e-mail to [email protected].