Senior HEOR Manager – Patient-Reported Outcome (12 months contract) m/f/d

Responsibilities

• Lead the development and execution of strategic COA plans for products across therapeutic areas, owning the COA Strategy Document for each program;
• Guide internal teams in selecting appropriate COAs for clinical trials and provide input into clinical documents throughout the trial lifecycle;
• Lead the scientific execution of COA projects with external vendors and internal stakeholders;
• Provide guidance to project teams, ensuring adherence to COA regulatory requirements and best practices;
• Oversee COA validation and interpretation, ensuring psychometric evidence meets regulatory and HTA criteria;
• Collaborate on COA data analysis and reporting, preparing regulatory or scientific documents as needed;
• Prepare COA-related regulatory and scientific submissions, leading relevant sections for regulatory agencies;
• S...