US Country Labeling - Durham, United States - The Accuro Group

Description

Business Title: | 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.