Regulatory Operations Specialist, Ogilvy Health

Ogilvy Health • Parsippany, NJ

6d

About The Position

We are looking for a Regulatory Operations Specialist to join our agency to prepare, submit and track MLR (Medical, Legal and Regulatory) submissions across our book of pharmaceutical clients. This includes preparing completed editorial content to submit to a Medical/Legal/Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and experts in FDA regulations). The ideal candidate is detail-oriented, highly accountable, and eager to learn the ins and outs of FDA regulations and the healthcare communications industry.

Requirements

• 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

Benefits

• Competitive benefits package

What This Job Offers

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