Digitas Health is the agency of now: the first global connected-health agency, bringing urgency to the abundant opportunity contained in today’s fluid and complex healthcare environment. Digitas Health brings together people who are driven to do great things with healthcare brands, who are frustrated by the status quo, and who are seeking new and better ways to engage with their customers. The agency’s contemporary and bold approach provides a practical path to transformative life-changing work and proven business growth.

JOB SUMMARY:

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

SKILLS & EXPERIENCE:

 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.

 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.

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