Regulatory Operations Specialist

Ogilvy Health is focused on driving superior outcomes in the ever-changing healthcare environment, an increasingly complex and evolving marketplace. We inspire brands and people to impact the world by keeping our audiences’ health and wellness needs at the center of every touchpoint. Ogilvy Health delivers insight, creativity, innovation, and engagement solutions for all healthcare stakeholders, patients, and consumers across the healthcare continuum. Through borderless creativity—operating, innovating, and creating at the intersection of Ogilvy’s capabilities and global talent—Ogilvy Health brings forth world-class creative solutions for its clients.

Over the past year alone, the Ogilvy network has been recognized with the following:

• Global Agency Network of the Year (Ad Age)
• Global Agency of the Year (Adweek)
• One of the “Best Places to Work” for LGBTQ+ equality (Human Rights Campaign’s Corporate Equality Index)
• Most Effective Agency Network (Effie Worldwide)
• Agency Network of the Year (Clio Awards)
• Network of the Year (One Show)
• Global Network of the Year (LIA Awards)
• Gartner Magic Quadrant Leader
• Most Awarded Agency (Influencer Marketing Awards)
• …and Ogilvy was the first agency network to secure the top rankings on both WARC’s Creative 100 and Effective 100 in consecutive years

For more information on us, visit OgilvyHealth.com, or follow Ogilvy Health on LinkedIn, Instagram, Facebook, X, and Threads.

About the Role

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.

What you’ll do:

• 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

What You’ll Need:

• 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

How We’ll Support You

Ogilvy celebrates its people. Fully. Enthusiastically. Unhesitatingly. We’ll empower you with the

tools you’ll need to succeed. We’ll give you the autonomy to seek out new paths and better ways of

doing things. We’ll support you with colleagues who are experts in their disciplines, drawn from

across the Ogilvy network. And we’ll provide opportunities for you to do work of which you’ll be

proud, with people you’ll be proud to call your teammates.

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