Pharma Regulatory Submissions Specialist

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

Job summary

Ogilvy is seeking a Regulatory Operations Specialist in Parsippany, NJ to prepare, submit, and track MLR submissions for our pharmaceutical clients. The role emphasizes attention to detail, accountability, and rapid learning of FDA regulations and healthcare communications.

You will assemble materials, route packages internally, coordinate timelines, and maintain archives, while collaborating with cross-functional teams and participating in client trainings.

Qualifications

• Self-motivated, highly organized, and detail-oriented with excellent time management skills.
• 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 the protocols established by our pharmaceutical clients
• Digitally route submission packages to internal team, facilitating communication cross-functionally
• Determine the time and effort needed to complete various components of each submission
• Handle multiple projects with different teams concurrently in a timely manner
• 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 & linking in Veeva Vault or other client software tools
• Work closely with the Project Management team to ensure smooth transition of files and accurate project timelines

Skills

Time management

Organizational skills

Communication skills

Independent work

Collaboration

Veeva Vault

Tools

Veeva Vault

Job description

Ogilvy is seeking a Regulatory Operations Specialist in Parsippany, NJ to prepare, submit, and track MLR submissions for our pharmaceutical clients. The role emphasizes attention to detail, accountability, and rapid learning of FDA regulations and healthcare communications.

You will assemble materials, route packages internally, coordinate timelines, and maintain archives, while collaborating with cross-functional teams and participating in client trainings.