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 todays complex and evolving landscape we partner with some of the worlds 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 culturewe 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 worlds leading communications networks.

At Digitas Health what sets us apart isnt just who we work with its 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 whats next. If youre energized by complexity motivated by impact and excited to help redefine how healthcare connects with people wed love to meet you!

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 bachelors 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 Différence means were 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

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