The contract Attorney will be reviewing claims within promotional materials for medical accuracy and completion.
- Provides strategic regulatory guidance on promotional materials and activities for commercial products in accordance with FDA regulations/guidance,
- Serves as the primary regulatory reviewer on the Promotional Review Committee (PRC)Acts as primary contact with FDA’s Office, OPDP including responding to agency inquiries and managing company requests for advisory review.
- Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.
- Works closely with Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.
- Provides regulatory strategy and operational support to product/portfolio assignments, including but not limited to general regulatory strategies, regulatory requirements in domestic and international markets, and regulatory submission requirements
- Leads the preparation and submission of documentation to support investigational and marketing registration packages and ensures timelines are met
- BS/BA Degree
- Minimum of 5 years' of experience in a pharmaceutical environment
- Thorough knowledge of OPDP guidelines and understanding of promotional review space
- Ability to understand and interpret clinical data
- Ability to provide input on the appropriate interpretation of references used in promotional materials
- General understanding of statistical analyses utilized in clinical trials
- Knowledge of regulations/guidance for advertising/promotion and labeling are a must
- Ability to work well in a team environment, be collaborative, and solution-oriented
- Experience with Veeva Vault
- Experience in drug development and registration activities a plus
Terms & Start:
- 12+ month contract
- Onsite Rockville, MD location 5/days a week post-pandemic
- Healthcare Benefits available
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