US Country Labeling & Regulatory Associate at The Accuro Group

Business Title: 102696 | US Country Labeling & Regulatory Associate
Location: Raleigh/Durham, NC 27709
Job Type: Contract (12 M+)
Note: Hybrid Position.

Job Responsibilities:

• Responsible for the production (authoring or assisting the authors), in terms of quality and regulatory acceptability of manuscripts for new/revised prescribing information for products marketed in the US.
• Identifies and resolves problems in a proactive manner.
• Suggests creative approaches to capture labeling concepts in a succinct manner.
• Ensures appropriate consistency in labeling documents across products for assigned area of responsibility.
• Works with Labeling Strategy staff to ensure compliance with US Labeling processes.
• Must be able to effectively articulate FDA and THE CLIENT requirements for labeling documents to THE CLIENT matrix teams, champion change, and recommend unique solutions, as needed.
• Ensures all labeling regulatory requirements associated with assigned products are met.
• Works with Matrix Team to resolve any labeling issues in a proactive manner.
• Ensures accurate version control of multiple labeling submissions and components.
• Develops FDA-compliant XML labeling documents for submission in accordance with THE CLIENT or FDA timelines.
• Works with internal Drug Listing experts to coordinate Drug Listing submissions via XML labeling.
• Produces all required versions of prescribing information documents for submission purposes and ensures all submission requirements are met for these documents.
• Completes all assigned tasks to project deadlines.
• Is able to manage own time at the task level and works on multiple projects in parallel.
• Provides summaries of Labeling updates as needed for NDA or BLA Annual Reports
• The major outputs of this position are:
• Provision of Regulatory advice regarding prescribing information requirements to a range of development projects and more broadly across the Global Regulatory Affairs and THE CLIENT Matrix Teams.
• Ensuring prescribing information for prescription products in the US meet all regulatory requirements.
• Production of FDA-compliant XML labeling documents.
• Ensuring proper version control of US prescribing information.

 Skills & Experience Required:

• Undergraduate Degree in a Science or Life Science area
• Labeling and Regulatory experience
• Knowledge of FDA regulations relevant to labeling
• Knowledge of XML labeling
• Familiarity with medical terminology required.