Senior Associate, Regulatory Operation

CoLab is a fully integrated cross-discipline team that provides best-in-class services in a fluid and modular way. With our clients at the center we create brand movement at the speed of peoples lives by connecting real-time data with world-class creative content and media in service of growth and Return on investment.

CoLab is a power of one solution encompassing data media and production. By drawing from across the vast Publicis Groupe network we are uniquely positioned to deliver innovation and specialized skills to our clients as well as enriching opportunities and inclusive benefits to our employees. We pride ourselves on combining the atmosphere of a startup company with the stability and experience of a global leader.

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

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.

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