Description

You will manage the production and regulatory quality of manuscripts for new and revised product prescribing information in the US market.

Responsibilities

• Author or assist in producing manuscripts to ensure quality and regulatory acceptability.
• Identify and resolve labeling issues proactively with matrix teams.
• Maintain consistency across all labeling documents for your assigned product area.
• Articulate FDA and client requirements to matrix teams to drive compliance and implement solutions.
• Collaborate with Labeling Strategy staff to ensure adherence to US labeling processes.

Required Skills

• 5+ years of relevant professional experience.
• Experience with XML.
• Proficiency with software tools.
• Knowledge of terminology relevant to the role.
• Experience using Matrixgold.
• Ability to ensure regulatory compliance for labeling documents.

Preferred Skills

• Bachelor's degree or equivalent experience.

Key Skills

Education

ANY GRADUATE