Promotional Material Specialist
Spectraforce TechnologiesMettawa, IL, United Statesjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionBachelor'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
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)
Qualification & Experience :
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Material Specialist • Mettawa, IL, United States