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 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 Operations is a project-level lead who is responsible for independently preparing promotional materials to be submitted to our pharmaceutical company clients Medical Legal Regulatory (MLR) review in accordance with both client specific standards and requirements as well as internal guidelines. The Senior Associate is responsible for tracking the progress of each project through the various stages of the MLR review process advising on submission timelines and following up directly with internal stakeholders as needed.

• Assemble submission packages through taking screenshots annotating pertinent information and attaching references and other ancillary documentation.
• Ensure components conform to both client and Digitas Health guidelines and requirements.
• Determine the time and effort required to create various components of each submission. Work directly with internal teams to develop submission timelines.
• Comfortably balance multiple projects simultaneously.
• Follow up with internal teams directly to communicate project status and timing expectations.
• Skillfully manage client expectations through clear and concise communication.
• Assist in maintaining departmental archive.

Required

• Minimum of a bachelors degree and 2-4 years of experience in the preparation of complex submission deliverables under tight deadline constraints
• Technical competency in Adobe Acrobat and the Microsoft Office Suite
• Clear communication and attention to detail
• Top notch organizational skills
• Clear concise technical writing ability

Preferred

• Experience working on cross-functional teams
• Working knowledge of Adobe InDesign and Photoshop

Desirable

• Experience in Pharmaceutical Industry Healthcare or similar environment
• Agency and/or project management experience

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.

#LI-AG2