Associate, Regulatory Operations

Senior Associate, Regulatory Operations

Digitas Health is the modern creative agency that takes on the biggest moments in healthcare, raises the standard of creative, and connects people, partners, and ideas to create work that earns its place in culture. Purpose-built for today's complex and evolving landscape, we partner with some of the world's largest healthcare brands to do big things by moving faster, connecting deeper, and unlocking new possibilities at the intersection of creativity, data, technology, and empathy. Guided by our purpose, Connected for Good, and fueled by a vibrant, magnetic culture we deliver meaningful work that drives relevance, changes behavior, and creates lasting impact, always grounded in humanity, not just technology. As part of Publicis Health and Publicis Groupe, we bring together entrepreneurial energy with the scale, stability, and depth of one of the world's leading communications networks.

At Digitas Health, what sets us apart isn't just who we work with, it's how we work and how it feels to be here. Our culture attracts curious, driven people who want to make a difference and be part of something bigger. Our teams are intentionally crafted across disciplines, perspectives, and experience levels, bringing strategy, creativity, data, and technology together from the start. We believe the best ideas come from curiosity, collaboration, and healthy debate and we expect people here to be thoughtful, engaged, and eager to shape what's next. If you're energized by complexity, motivated by impact, and excited to help redefine how healthcare connects with people, we'd love to meet you!

Overview

The Senior Associate, Regulatory Review must follow the protocol established by our pharmaceutical company clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and experts in FDA regulations), submitting materials to the client (both electronically and/or in hard copy as determined by the clients' specifications), and tracking the progress of each project through the various stages of MLR review.

Responsibilities

• Determine the time and effort required to complete each submission
• Establish a timeline and assign responsibility to the appropriate team members for the delivery of the components of the submission
• Create and/or oversee the creation of the components and ensure they conform to client and Digitas Health guidelines
• Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines
• Follow up with client liaison in a timely manner to ensure the submission is received on time and meets 100% of client expectations and specifications
• Act as the primary point of contact between the agency and the clients' MLR Review department, both to get information regarding submissions requirements and to answer procedural questions that arise during the MLR review process
• Create, update, and disseminate to the rest of the department procedure(s) specific to the clients supported

Qualifications

• Minimum of a bachelor's degree and 2-4 years of experience in the preparation of complex deliverables under tight deadline constraints is required.
• Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required.
• Experience communicating with clients directly is required.
• Clear communication and attention to detail are essential.
• Clear, concise technical writing ability is strongly preferred.
• Experience in Pharmaceutical Industry or Healthcare is preferred.

Note: This job specification should not be construed to imply that these requirements are the exclusive standards of the position. Performs other duties (or functions) as assigned.

Our Publicis Groupe motto "Viva La Diffrence" means we're better together, and we believe that our differences make us stronger. It means we honor and celebrate all identities, across all facets of intersectionality, and it underpins all that we do as an organization. We are focused on fostering belonging and creating equitable & inclusive experiences for all talent.

Publicis Groupe provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.

If you require accommodation or assistance with the application or onboarding process specifically, please contact USMTTACompliance@publicis.com.

All your information will be kept confidential according to EEO guidelines.

Compensation Range: USD $25.94 - USD $34.43/Hourly. This is the pay range the Company believes it will pay for this position at the time of this posting. Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time. Temporary roles may be eligible to participate in our freelancer/temporary employee medical plan through a third-party benefits administration system once certain criteria have been met. Temporary roles may also qualify for participation in our 401(k) plan after eligibility criteria have been met. For regular roles, the Company will offer medical coverage, dental, vision, disability, 401k, and paid time off.