This role is responsible for supporting regulatory review and activities related to advertising/promotion of marketed pharmaceutical products in oncology, endocrinology, and hematology. The position requires an understanding of regulatory frameworks, strategic thinking, and the ability to navigate complex regulatory compliance requirements.
Requirements
- Direct regulatory review of US/Canadian commercial product and disease state materials/communications
- Ensures promotional materials meet ad/promo regulatory and company requirements
- Ensures timely review of materials to meet internal timelines, requirements, and compliance with approved product labels
- Submits product promotional material to OPDP (Office of Prescription and Drug Promotion) on Form FDA 2253 in a timely manner as per regulations
- Coordinates cross-functionally and drives to resolution issues that impact promotional activities
- Provides insights and guidance to multiple functional areas on the development of product messages, assets, programs, tactics, etc.
- Reviews concepts, materials, and communications used in scientific exchanges; represents Regulatory Affairs on the Medical Review Committee (MRC)
- Maintains up-to-date knowledge of laws, regulations, and policies enforced by FDA as they relate to advertising/promotion of pharmaceuticals products
- Handles additional duties and special projects, as assigned by the Director of RA Ad/Promo
- Continually assesses ad/promo-related processes to enhance efficiency and compliance
- Monitors competitor advertising to keep abreast of market promotional and advertising strategies
- Monitors OPDP enforcement actions and assesses potential learnings/impact
Benefits
- Health Insurance
- Retirement Benefits: 401k
- Paid Time Off: Vacation, holiday, and sick/personal time