Global Regulatory Affairs Scholar

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

1d•Hybrid

About The Position

The Global Regulatory Affairs (GRA) Scholar Program at Johnson & Johnson is a two-year experiential fellowship designed for recent university graduates. It offers advanced, hands-on professional development within one of the world’s leading healthcare companies. Under the mentorship of J&J regulatory professionals, GRA Scholars will complete multiple rotations across various disease-therapeutic areas and related regulatory functions, such as Product Labeling, Policy and Intelligence, and Chemistry, Manufacturing and Controls. The program aims to develop a broad understanding of the global drug development lifecycle and strategies for engaging health authorities, while learning the laws, guidance, and regulatory requirements for drugs and combination products. Scholars will also tackle real-world projects to build leadership presence, strengthen influence, and enhance collaboration, problem-solving, and presentation skills, while growing their professional network and cross-functional exposure.

Requirements

Earned a bachelor's degree (B.S. or B.A.) from a 4-year university program.
Earned or is currently pursuing an advanced degree (PhD/PharmD) in scientific, technology or engineering related field from an accredited academic institution. Examples include, biomedical engineering, data analytics/applied statistics, quantitative modeling in biology, pharmacy or other healthcare science.
Strong academic track record is required.

Nice To Haves

Some fundamental understanding of pharmaceutical drug development.
Knowledge of current Food and Drug Administration (FDA) regulations, guidelines, and submission requirements is desired.
Proven leadership capabilities in an organizational setting (campus/community activities) is desired.
Able to work independently, as well as, be part of a group, with curiosity and flexibility.
Be self-motivated, possess a “can do” approach, and courage to speak your voice and suggest innovative ideas.
Be a creative problem solver, with an interest in exploring the international context of healthcare systems and technology contexts.
Analytical Reasoning
Business Behavior
Business Writing
Communication
Confidentiality
Data Reporting
Detail-Oriented
Legal Support
Medicines and Device Development and Regulation
Problem Solving
Product Licensing
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Teamwork

Responsibilities

Develop a broad understanding of the global drug development lifecycle and related strategies for engaging health authorities.
Learn the laws, guidance’s, and regulatory requirements for drugs and combination products while staying aligned with the organization’s goals.
Tackle real-world projects that build your leadership presence, strengthen your ability to influence stakeholders, and enhance your collaboration, problem-solving, and presentation skills.
Grow your professional network and cross-functional exposure while working with different teams.
Participate in internal and external meetings to support your role’s responsibilities.
Own a complex capstone project and present results to GRA senior leaders and other internal partners.

Benefits

an annual performance bonus
medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
Company’s consolidated retirement plan (pension)
savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours