Regulatory Submissions Specialist — Pharma & MLR

Ogilvy Health; Parsippany-Troy Hills (NJ); On-site; USD 40,000 - 85,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Ogilvy Health in the United States seeks a Regulatory Operations Specialist to prepare, submit, and track MLR submissions for pharmaceutical clients. The role focuses on editorial content prepared for Medical/Legal/Regulatory review and requires attention to FDA regulations and healthcare communications experience.

The candidate should be detail-oriented, highly accountable, and eager to learn the regulatory landscape.

Qualifications

• Self-motivated, highly organized with excellent time management.
• Previous project management, healthcare, or pharmaceutical industry experience preferred.
• Ability to work effectively both independently and collaboratively to meet deadlines.
• Experience with Veeva Vault platform preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Assemble and deliver marketing materials for regulatory review following client protocols.
• Digitally route submission packages to internal teams.
• Determine time and effort needed for each submission component.
• Handle multiple projects with different teams concurrently.
• Assist in maintaining departmental archives and documentation.
• Attend client-led trainings on submission platform requirements.
• Provide QA and oversight for submission packages.
• Complete medical reference tagging and linking in Veeva Vault or client software.
• Collaborate with Project Management to ensure smooth file transitions and accurate timelines.

Skills

Self-motivation

Project management

Healthcare/pharma experience

Independent and collaborative work

Veeva Vault

Excellent communication skills

Tools

Veeva Vault

Job description

Ogilvy Health in the United States seeks a Regulatory Operations Specialist to prepare, submit, and track MLR submissions for pharmaceutical clients. The role focuses on editorial content prepared for Medical/Legal/Regulatory review and requires attention to FDA regulations and healthcare communications experience.

The candidate should be detail-oriented, highly accountable, and eager to learn the regulatory landscape.