Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a US Risk Management Associate Lead in the Titusville, New Jersey location.

The US Risk Management Associate Lead supports the development, implementation, monitoring, and assessment of Risk Evaluation and Mitigation Strategies (REMS) and general US risk management strategy under the oversight of the Risk Management Lead and REMS & Risk Management Center of Excellence (RRM CoE).

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, hematology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management and vaccines, and cardiovascular and metabolic diseases.

Please visit http://www.JanssenRnD.com for more information.

Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

The REMS & Risk Management Center of Excellence is responsible for the design, implementation, management, and assessment of Risk Evaluation and Mitigation Strategies (REMS) within Janssen

This includes:

• Department Operations and Internal Partner Support
• Support REMS Assessment Report project planning, data collection, development, review, and approval
• Propose and/or assist in the development of REMS modifications
• Lead or support operational implementation of REMS program elements and modifications
• Support REMS Core Team meetings
• Develop strong working relationship with REMS Core Team members
• Provide REMS Core Team with status reports, proposals, and materials for review and approval
• Train internal and external stakeholders about the REMS programs
• Assist and lead development of and updates to REMS SOPs as appropriate
• Contribute to electronic review, approval, and archiving software, including development of new REMS specific workflows
• Develop and maintain robust files for all REMS related documents
• Manage audit CAPAs when necessary
• Coordinate response development for FDA information requests
• Manage vendor in development, revision, and execution of survey studies to measure the effectiveness of the REMS programs

Qualifications:

• Bachelor’s Degree, life sciences preferred
• At least 3 years of experience, of which 1 year in REMS, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Medical Writing, or similar; equivalent combination of advanced degree and less experience will be considered
• Knowledge and experience with FDA regulatory aspects of prescription drug development end-to-end.
• Experience with various types of US submissions including generics
• Familiar with risk management program operations, including call center, database development and management, and effectiveness assessment
• Familiar with regulatory aspects at various stages of development, from entry-into-man to post approval activities
• Familiarity with clinical trial methodology and statistics
• Ability to influence within the same function or cross-functionally and or globally
• Excellent communication, interpersonal, negotiation and problem – solving skills
• Up to 10% travel

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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PRIMARY LOCATION

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

ORGANIZATION

Janssen Scientific Affairs, LLC (6120)

JOB FUNCTION

Regulatory Affairs

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

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