Regulatory Operations Specialist, Ogilvy Health

Ogilvy • Parsippany, NJ

6d

About The Position

Ogilvy Health is seeking a Regulatory Operations Specialist to manage Medical, Legal, and Regulatory (MLR) submissions for its pharmaceutical clients. This role involves preparing and submitting marketing materials for review by an MLR board, which typically includes medical doctors, lawyers, and FDA regulatory experts. The ideal candidate will be detail-oriented, accountable, and keen to learn about FDA regulations and the healthcare communications sector.

Requirements

• Self-motivated, highly organized, and detail-oriented with excellent time management skills.
• Ability to work effectively both independently and collaboratively to meet deadlines.
• Excellent written and verbal communication skills.

Nice To Haves

• Previous project management, healthcare, or pharmaceutical industry experience.
• Experience with Veeva Vault platform.

Responsibilities

• Assemble and deliver marketing materials for regulatory review following client protocols.
• Digitally route submission packages to internal teams and facilitate cross-functional communication.
• Determine the time and effort required for submission components.
• 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.
• Work closely with the Project Management team to ensure smooth file transitions and accurate project timelines.

Benefits

• Tools to succeed
• Autonomy to seek new paths
• Support from expert colleagues
• Opportunities to do proud work
• Teammates you'll be proud to call your own

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed