Associate Director, Promotion Compliance
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About The Position
Independently reviews, revises, and approves content and context required of promotional labeling materials for prescription drug and medical device products. Must be effective in managing work and resolving conflicts. Must demonstrate a high level of understanding of regulations related to promotion compliance. May be assigned additional responsibilities as deemed necessary. Directs or assists junior staff member(s) or independently reviews, revises and approves content and context required of promotional labeling materials for prescription drug and medical device products. Ensures that promotional labeling and training material meet regulatory and company requirements. Provides alternative suggestions to allow for consistent messaging. Serves as the primary contact/liaison with the FDA Office of Prescription Drug Promotion (OPDP), responsible for establishing working relationship and managing communication with OPDP reviewers for advertising and promotion matters, including advisory comments. Provides training to OAPI/OPDC employees on regulations for labeling and promotion compliance as appropriate. Monitors and informs others of changes in US labeling and promotional regulations as well as corporate policies and procedures, as appropriate. Recommends improvements to labeling policies, processes, quality, and system tools. Manages contracts for contractors and consultants. Contributes to SOPs for review and submission and of advertising and promotional materials. Implements strategies to apply labeling updates that impact promotional materials. Collaborates with all review team members during development of promotional materials or other types of product communications to provide comprehensive regulatory compliance guidance. Ensures product promotional materials are submitted to OPDP on Form FDA 2253 in a timely manner as per regulations, and that materials are archived as per company policy.
