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Job Description:

Johnson & Johnson, is recruiting for a Sr. Director, Real World Evidence (RWE) and Reliance Policy to be located in Raritan, NJ or Washington, DC. Remote work options may be considered on a case-by-case basis and if approved by the Company (East Coast preferred).

The Sr. Director will drive innovative ways to advance new sources of data (including real world data), and regulatory reliance pathways for global drug development. The leader will engage in a multifaceted and dynamic global regulatory environment, supporting innovative and collaborative approaches. The policy lead will provide oversight and responsibility for strategic direction, to improve outcomes and promote effective development and of products globally.

Key Responsibilities include, but are not limited to the following:

• Advance innovative ways to use real world evidence (RWE) for regulatory purposes

• Drive use of reliance approaches to improve delivery of products to patients globally

• Ensure that global RWE and reliance approaches are optimally reflected in policy strategic plans, and advanced through innovative advocacy

• Apply understanding of the external environment to support Global Regulatory Affairs and promote novel product development approaches

• Provide insights to the policy team and partners to build effective advocacy approaches to global regulatory policy priorities

• Coordinate appropriate participation in Trade Association initiatives, as well as commenting on guidance documents and regulatory programs.

• Provide expert help and interpretation of meaningful regulatory policy issues affecting adoption of innovative evidence acceptance by regulators globally

• Actively participate in the GRPI Leadership Team to develop and meet goals and objectives.

Education:

• Bachelor’s degree experience in science, and Master's or equivalent experience in health, law, policy, or science

Required:

• 5 years proven experience in related area

• 3 years at a regulator, preferably the US FDA

• Deep understanding of health authorities, including in US, EU, and Asia-Pacific

• 2 years in regulatory or policy

• Strong digital competence

• Travel percentage 10-15% domestic and international.

Preferred:

• 8 years in a related area

• 5 years at the US FDA

• A minimum of 3 years in regulatory or policy

• 2 years in pharmaceutical industry

• Very strong understanding of regulators, in US, EU, and AP

• Outstanding digital competence

The anticipated base pay range for this position is $173, 000 to $299, 000.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

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• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company’s long-term incentive program.

• Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found via the following link: https: //www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.