Sr. Director, Real World Evidence (RWE) and Reliance Policy

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 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 humanity. Learn more at https://www.jnj.com

Job Function:
Communications & Corporate/External Affairs

Job Sub Function:
Government Affairs & Policy

Job Category:
People Leader

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

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 i...