Promotional Material Specialist

Position Title: Promotional Material Specialist

Work Location: Remote

Assignment Duration: 02 Years

Summary: Manages review and approval process for promotional, non-promotional and internal use materials. Manages electronic approval system, user access, user training and workflows. Supports FDA Ad Promo Submissions. Supports QC and regulatory reviews of the materials.

Key Responsibilities:

• Coordinate promotional and non-promotional materials review and approval processes
• Maintain in-depth knowledge of approval process routing grids per SOP and route the materials for approvals accordingly
• Perform Quality Check review on the materials prior to routing
• Collaborate with sponsors and agencies to develop and plan PRC meeting agenda
• Facilitate the PRC meeting discussions and document outcome in live meetings while conducting meeting efficiently to cover the full agenda
• Collaborate with marketing operations on prioritization for routine approvals as well as during major campaign launches and label updates.
• Complete regulatory review of promotional and non-promotional materials, final reviews, reapprovals and other review types as necessary
• Develop and update training resources on materials review process and Veeva functionality. Train sponsors, agencies, and reviewers as needed
• Manage user profiles, training needs and access to the VeevaPromomats to sponsors, agencies, and reviewers
• Serve as a point of contact to Veeva vendor for ongoing maintenance and optimization of Veeva workflows. Assist with Veeva Promomats IT validation
• Generate Veeva metric reports to help with process improvement, resource management and compliance monitoring
• Archive OPDP correspondence per guidance from Reg Ad promo lead
• Contribute to development and update of departmental work instructions
• Prepare materials, form 2253, cover letter and send them over to Reg Operations for publishing and OPDP submission
• Support other departmental initiatives as needed (e.g. process improvements)

• Bachelor's degree in technical or science related discipline or related work experience
• Preferred: 3 years in Regulatory, Quality or related area
• Document-Quality Check
• Good organizational and time management skills
• Strong communication, both oral and written
• Ability to innovate, analyze, understand customers' needs with minimal supervision
• Proficient with computer systems and/or pharmaceutical software
• Experience in a complex and matrix environment
• Experience in pharmaceutical industry preferred
• Past experience in prescription drug advertising/promotional labeling and/or promotional labeling submissions desired
• Knowledge of procedures and requirements regarding prescription drug advertising and promotional materials desired
• Proficient with computer systems and/or pharmaceutical software
• Science background is a plus