Senior Regulatory Submissions Lead

Publicis Groupe ANZ; Philadelphia, Northern (Philadelphia County, KY); Hybrid; USD 36,000 - 47,000; Full time

Job summary

Digitas Health, part of Publicis Groupe, seeks a Senior Associate, Regulatory Operations in the US to lead submission packages for pharmaceutical MLR review. You will independently prepare materials, track progress, and advise on timelines while coordinating with internal teams and stakeholders to meet client standards.

The role requires a bachelor’s degree and 2–4 years’ experience, plus strong skills in Adobe Acrobat and MS Office.

Qualifications

• Minimum of a bachelor's 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

Responsibilities

• 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.

Skills

Clear communication

Attention to detail

Organizational skills

Technical writing

Education

Bachelor's degree

Tools

Adobe Acrobat

Microsoft Office Suite

Adobe InDesign

Photoshop

Job description

Digitas Health, part of Publicis Groupe, seeks a Senior Associate, Regulatory Operations in the US to lead submission packages for pharmaceutical MLR review. You will independently prepare materials, track progress, and advise on timelines while coordinating with internal teams and stakeholders to meet client standards.

The role requires a bachelor’s degree and 2–4 years’ experience, plus strong skills in Adobe Acrobat and MS Office.