PRC Coordinator

Melinta; New Jersey; On-site; USD 90,000 - 96,000; Full time

Job summary

CorMedix Therapeutics, a biopharmaceutical company focused on addressing life-threatening conditions in the US, seeks a highly organized PRC/MRC Coordinator to support promotional review operations. You will manage end-to-end workflows, verify submissions, and maintain accurate records within Veeva Vault PromoMats.

The role requires collaboration with Commercial, Medical Affairs, Regulatory, Legal, and Compliance functions, ensuring timely reviews and adherence to regulatory requirements in a

Qualifications

• Bachelor's degree in Life Sciences, Marketing, Communications, Business, or a related discipline required.
• Minimum of 3 years of experience supporting promotional review, MLR/PRC operations, regulatory operations, marketing operations, or related functions within the pharma/biotech/healthcare industry.
• Hands-on experience with Veeva Vault PromoMats, including workflow management, routing, metadata governance, lifecycle management, annotations, version control, and reporting.
• Experience coordinating cross-functional review processes involving Commercial, Medical, Regulatory, Legal, and Compliance stakeholders.
• Familiarity with FDA advertising and promotion regulations and promotional material lifecycle management.
• Demonstrated ability to manage multiple projects and deadlines in a fast-paced environment.

Responsibilities

• Coordinate the end-to-end workflow for promotional and medical communications materials through the PRC/MRC review process.
• Review submissions for completeness and quality with required documentation and metadata.
• Verify materials are classified, routed, and assigned to correct reviewers and stakeholders.
• Manage review timelines and monitor workflow progress to ensure efficiency.
• Identify bottlenecks and risks, and escalate as needed.
• Coordinate expedited reviews and ensure compliance with procedures.
• Track approvals, revisions, renewals, and lifecycle milestones.

Skills

Project management

Cross-functional collaboration

Attention to detail

Communication

Regulatory knowledge

Education

Bachelor's degree in Life Sciences/Marketing/Communications/Business

Tools

Veeva Vault PromoMats

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full-time Regular Parsippany, NJ, US

Salary Range: $90,000.00 To $95,500.00 Annually

Why CorMedix Therapeutics?

If you are interested in joining an entrepreneurial team, focused on bringing life-saving therapies to market for critical unmet medical needs, consider applying for a role at CorMedix Therapeutics. The culture at CorMedix Therapeutics is patient-centered where we feel a sense of urgency to solve some of the most pressing issues in hospital-based healthcare.

CorMedix Therapeutic’s greatest asset is our people. We have a deeply experienced team and continue to bring on some of the brightest talent that can problem solve and execute with high precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose. We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs.

Company Description:

CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. Rezafungin is currently approved for the treatment of candidemia and invasive candidiasis in adults. For more information visit: www.cormedix.com .

Position:Promotional Review Committee (PRC) / Material Review Committee (MRC) Coordinator

Position Summary:CorMedix is seeking a highly organized and detail-oriented Promotional Review Committee (PRC) / Material Review Committee (MRC) Coordinator to support the operational execution of the Company's promotional review process. This role serves as the primary coordinator for the review, approval, tracking, and lifecycle management of promotional materials within Veeva Vault PromoMats.

The PRC/MRC Coordinator partners closely with Commercial, Medical Affairs, Regulatory Affairs, Legal, Compliance, and external agencies to ensure promotional materials are accurately routed, reviewed, documented, and maintained in accordance with company procedures and applicable regulatory requirements. This individual plays a critical role in maintaining efficient review workflows, supporting committee operations, ensuring system integrity, and driving continuous process improvement across the promotional review function. The ideal candidate combines strong project management, communication, and organizational skills with a solid understanding of promotional review processes and systems. This role requires the ability to manage multiple priorities, collaborate effectively across functions, and maintain a high level of accuracy in a fast-paced environment.

Primary Responsibilities:

Promotional Review Operations

• Coordinate the end-to-end workflow for promotional and medical communications materials through the PRC/MRC review process.
• Review incoming submissions for completeness and quality, ensuring required documentation, references, metadata, and supporting materials are included prior toreview initiation.
• Verify promotional materials are appropriately classified, routed, and assigned to the correct reviewers and stakeholders.
• Manage review timelines and monitor workflow progress to ensure materials move efficiently through the review process.
• Identify, communicate, and elevate potential bottlenecks, competing priorities, and workflow risks.
• Coordinate expedited reviews and facilitate resolution of review-related issues while maintaining compliance with established procedures.
• Track approvals, revisions, re-approvals, renewals, expirations, and lifecycle milestones for promotional materials.

PRC/MRC Meeting Management

• Schedule, organize, and facilitate PRC/MRC meetings.
• Prepare and distribute meeting agendas, review materials, reference packages, and supporting documentation.
• Capture reviewer feedback, committee decisions, action items, and approval outcomes.
• Ensure timely follow-up and incorporation of required revisions following committee review.
• Maintain accurate meeting records and approval documentation in accordance with company procedures.
• Support day-to-day administration of Veeva Vault PromoMats, including workflow management, metadata governance, lifecycle tracking, reporting, and user support.
• Ensure materials are appropriately tagged, categorized, and maintained within the system in accordance with established business rules and procedures.
• Assist with user access requests, troubleshooting, training, and documentation updates.
• Partner with internal stakeholders and external vendors to support system enhancements and operational efficiencies.

Compliance, Reporting, and Continuous Improvement

• Perform quality checks to ensure materials align with approved labeling, fair balance requirements, required disclosures, and internal standards.
• Support Regulatory Operations by coordinating approved materials for regulatory submission activities, as applicable.
• Monitor operational metrics, including review cycle times, throughput, and workflow performance.
• Analyze trends and identify opportunities to improve review efficiency, quality, and stakeholder experience.
• Develop and maintain SOPs, work instructions, training materials, and process documentation.
• Support implementation of process improvements and best practices across promotional review operations.
• Serve as a resource to stakeholders by providing guidance on PRC/MRC processes, systems, and operational requirements.

Skills & Requirements:

Qualifications:

• Bachelor's degree in Life Sciences, Marketing, Communications, Business, or a related discipline required.
• Minimum of 3 years of experience supporting promotional review, MLR/PRC operations, regulatory operations, marketing operations, or related functions within the pharmaceutical, biotechnology, medical device, or healthcare industry.
• Hands-on experience with Veeva Vault PromoMats, including workflow management, routing, metadata governance, lifecycle management, annotations, version control, and reporting.
• Experience coordinating cross-functional review processes involving Commercial, Medical, Regulatory, Legal, and Compliance stakeholders.
• Familiarity with FDA advertising and promotion regulations, OPDP considerations, and promotional material lifecycle management.
• Demonstrated ability to manage multiple projects, stakeholders, and deadlines in a fast-paced environment.
• Excellent organizational, communication, facilitation, and stakeholder management skills.
• Strong attention to detail with the ability to maintain accurate documentation while understanding broader operational objectives.
• Proficiency with Microsoft Office applications, including Outlook, Teams, Excel, PowerPoint, and SharePoint.
• Experience supporting commercial launches, promotional review metrics and reporting, or global review teams is preferred.
• Ability to work independently while collaborating effectively across cross-functional teams.

Work Location:

• This role is based in Parsippany, New Jersey and requires regular onsite presence at the corporate headquarters on designated in-office days.

Travel Requirements:

• Ability to travel up to 10% as needed for meetings, conferences, and company events.