Associate Director, Patient Reported Outcomes

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 more at

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

Job Description:

ASSOCIATE DIRECTOR PATIENT REPORTED OUTCOMES

About Innovative Medicine

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.

Learn more at are searching for the best talent for Associate Director Patient Reported Outcomes to be located in Raritan NJ.

Purpose:

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.

You will be responsible for:

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.

Qualifications / Requirements:

A Masters degree or PhD in the field of psychology psychometrics sociology health economics biostatistics epidemiology public health or health services research or PharmD.

A minimum of 4 or more years of Patient Reported Outcomes experience is required.

A minimum of 2 or more years of experience in project management is required.

Experience in the strategy conceptual basis methodology and application of PRO and other health outcome measures in the context of clinical studies is required.

Experience with the development psychometric evaluation and selection of PRO instruments used in clinical studies is required.

Working knowledge Patient Focused Drug Development initiatives the 2009 FDA Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims and other relevant guidance and best practices is required.

Experience managing budgets is preferred required.

Ability to work effectively as a member of cross-functional teams is required.

Excellent oral written and presentation skills are required.

Ability to work in a matrix environment is required.

Capable of leading and influencing teams and driving decisions is strongly preferred.

Experience with the drug development process in the pharmaceutical industry is strongly preferred.

Regulatory understanding in negotiating PRO label claims is strongly preferred.

Experience with ePRO is preferred.

This position will require up to 10% of both domestic and international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:

Agility Jumps Clinical Outcomes Commercial Awareness Competitive Landscape Analysis Cross-Functional Collaboration Customer Intelligence Global Market Go-to-Market Strategies Health Economics Health Intelligence Market Knowledge Market Opportunity Assessment Mentorship Organizing Patient Outcomes Patient Reported Outcomes Pricing Strategies Regulatory Compliance Strategic Change Tactical Planning Technical Credibility

The anticipated base pay range for this position is :

$137000.00 - $235750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys long-term incentive program.



Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

Work Personal and Family Time - up to 40 hours per calendar year

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Director