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)

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