Associate – Regulatory Review

Job Description

The Associate, Regulatory Review works closely with the internal client team and the rest of the Regulatory Review department in the preparation and delivery of materials for submission to our pharmaceutical company clients for regulatory review. This includes creating components of a submission package (both electronically and/or in hard copy as determined by the clients’ specifications), trafficking submission packages during their routing to internal client team members, facilitating communication among team members about the status of projects currently underway, and data entry.

DUTIES & RESPONSIBILITIES:

• Determine the time and effort required to create various components of each submission for a Manager, Regulatory Review or Senior Associate, Regulatory Review
• Ensure components conform to client and Digitas Health guidelines
• Produce and assemble submission packages
• Comfortably handle multiple projects and work with multiple teams concurrently
• Skillfully manage client expectations
• Assist in maintaining departmental archive
• Ensure adequate supplies for departmental production and shipping needs

Qualifications

Minimum of a bachelor’s degree and 2 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. Clear communication and attention to detail are essential. Clear, concise technical writing ability is strongly preferred. Experience in Pharmaceutical Industry or Healthcare is preferred.