Associate Director, Patient Reported Outcomes

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Market Access

Job Sub Function:
Health Economics Market Access

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‑based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for Associate Director, Patient Reported Outcomes, to be located in Raritan, NJ.

The Associate Director, Patient Reported Outcomes (PRO) works closely with the PRO team to facilitate PRO‑related activities in support of studies conducted for products in development in the Janssen R&D organization. The PRO Associate Director is responsible for managing PRO‑related activities for assigned compounds in development, as well as for providing scientific expertise in measurement and psychometric analytic issues across therapeutic areas.

The PRO Associate Director may be responsible for leading the PRO program and be responsible for all PRO‑related aspects for a compound. The PRO Associate Director provides background information on competitor drug PRO research, conducts PRO literature searches, conducts qualitative research, works with the cross‑functional teams to incorporate PRO instruments into clinical studies, oversees analyses and publications, and generally represents the PRO function in clinical trial working groups and other teams.

• Lead activities under the direction of a PRO Lead.
• Provide clinical teams with the information necessary for the appropriate incorporation of PRO measures in clinical studies.
• Provide information and guidance in choosing appropriate PRO instruments for clinical studies.
• Determine availability of selected PRO instruments and their translations for inclusion in clinical trials; and to implement any validation studies required; and to provide PRO training and materials for trial investigators.
• Ensure appropriate PRO data capture methods (including ePRO) and processes are implemented.
• Oversee psychometric analyses and work with statisticians and cross‑functional team members on PROs included in protocols, statistical analysis plans, and clinical study reports.
• Participate in preparing relevant:
• Sections of documentation and communication for regulatory agencies in support of submission activities.
• Preparing internal communications and presentations e.g. PRO strategy documents.
• PRO analyses and sections of dossiers for HTA submissions.
• Abstracts and manuscripts presenting PRO results.
• Identify, evaluate and manage projects with researchers and PRO vendors external to the company, including but not limited to qualitative research, cultural validation studies, validation studies for special populations, and quantitative analyses.
• Manage budgets and contracts for PRO projects.
• Ensure PRO activities are captured in a shared electronic PRO repository.

• A Master’s degree or PhD in the field of psychology, psychometrics, sociology, health economics, biostatistics, epidemiology, public…