Commercial Regulatory Affairs (CoRA) Advertising & Promotions (AdPro) Coordinator/Associate
This position is responsible for coordinating the review and approval process for the Copy Review Committee (CRC) meetings. This involves managing the advertising and promotional materials review and approval process, and ensuring the Business owners and reviewers follow all applicable company policies and guidelines. The Advertising and Promotion Commercial Regulatory Associate is responsible for properly documenting all steps of the process and working cross functionally with Legal, Medical, Commercial Regulatory, and Marketing when defining priorities and building appropriate timelines. The Commercial Regulatory Associate is required to act as a project manager responsible for moving each project through the process from initial review to final approval and submission to FDA as needed.
This is a critical role that ensures all advertising and promotional materials are reviewed and approved according to the process outlined in the SWP. Once materials are approved, the Commercial Regulatory Associate is responsible for documenting all approvals and working closely with Global Regulatory Operations to ensure appropriate samples are sent to FDA
Train organization and vendors on CRC Process, including the review and approval of materials through electronic CRC system
Ensure adherence to CRC SWP; Oversee and manage the review and approval process for CRC materials
Collaborate with Business owner and Commercial Regulatory reviewer to set realistic agendas and ensure the timely distribution of agenda and materials; Review materials submitted for CRC review to determine appropriateness and completeness prior to scheduling CRC meeting
Support Business owner with facilitation of CRC meeting and capture of reviewer comments
As needed, act as a liaison with vendors to ensure incorporation of CRC comments
Assist Commercial Regulatory reviewer with review of resubmitted pieces and final flats and ensure all requested changes have been incorporated; Manage proof reading process of promotional items prior to release to printer and submission to FDA as needed
Prepare CRC approved materials for submission to FDA on Form 2253 at time of first use
Generate reports to evaluate a variety of metrics related to the review and approval of materials through CRC. Provide Business owners with expiration reports to ensure all materials are scheduled for a timely annual review prior to expiration and retirement from use.
• Provide monthly expiration reports to the brand teams on CRC approved materials
• Generate reports that measure a variety of metrics, including quantity of materials reviewed, quantity of materials resubmitted for review, materials submitted to FDA, etc.
• Manage relationships with vendors by actively participating in weekly status calls ensuring that all projects deadline lines are met
• Bachelor’s Degree with pharmaceutical industry work experience (1-3 years) preferred
• Excellent written and oral communication skills including ability to train and present effectively
• Attention to detail (including proof reading skills)
• Process orientation and management is critical
• Excellent project management skills including meeting facilitation, organization and time management
• Experience in vendor management
• Documentation and record keeping skills
• Microsoft Office, including Excel, Word and PowerPoint