Sr. Regulatory Affairs Associate, Advertising & Promotional Operations

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Purpose:
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.

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 and CMRC 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 primary 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. eCTD transition)
• Train and supervise contractor (s) supporting Reg Ad Promo operations

Qualifications

• Bachelor's degree in technical or science related discipline or related work experience
• Preferred: 3 years in Regulatory, Quality or related area
• 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

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.