Spectraforce Technologies
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:
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
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:
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