Spectraforce Technologies
Position Title:
Promotional Material Specialist
Work Location:
Mettawa, IL 60045
Assignment Duration:
2 years
Work Arrangement:
Hybrid
Position 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:
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
Experience Level = 5-7 Years
Promotional Material Specialist
Work Location:
Mettawa, IL 60045
Assignment Duration:
2 years
Work Arrangement:
Hybrid
Position 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:
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
Experience Level = 5-7 Years