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:** Career Programs **Job Sub** **Function:** Non-LDP Intern/Co-Op **Job Category:** Career Program **All Job Posting Locations:** Raritan, New Jersey, United States of America **Job Description:** 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/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Johnson & Johnson Innovative Medicine is offering an industrial pharmacy rotation for students as part of the Advanced Pharmacy Practice Experience (APPE) program in 2025 to support Global Regulatory Affairs (GRA). The APPE rotation will be based remotely. There are many career opportunities available to today’s pharmacists. The purpose of this rotation is to expose the senior pharmacy student to the field of GRA covering pharmaceutical drug therapy development and product commercialization. Most importantly, this APPE rotation will provide students with an opportunity to work alongside a pharmacist providing meaningful input for the research & development of therapies. In addition, the participant will learn the various issues surrounding the field of GRA and work with other relevant departments within Johnson & Johnson Innovative Medicine. The APPE rotational student will support activities related to GRA. The incumbent will support projects related to the research & development of investigational and/or approved drugs. Key Experiences: + Work on programs and strategies for compounds in development and/or marketed products. + Gain experience and exposure in drug development intended to address unmet medical needs in markets globally through an understanding of laws, guidances, and regulatory requirements for drugs +/- combination products. + Use creative problem-solving skillsets to develop new ideas and insights, including takeaways about yourself as a leader. + Develop diverse skills and experiences in building solutions for real-life business challenges through hands-on projects. Potential growth opportunities during the APPE may include, but are not limited to: + Support the management of regulatory or drug development issues + Gain knowledge of the U.S. FDA regulations and guidelines + Improve communication, collaboration, negotiation and problem solving skills + Grow knowledge of regulatory processes and documents, knowledge of therapeutic areas + Think strategically with good project management skills + Contribute to the completion of project milestones and organize own work to meet project task deadlines + Ensure compliance with the submission standards, procedures and policies framed by Global Regulatory Affairs and Standard Operating Procedures + Identify and assess regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. + Liaise with NA Regulatory Scientist, Submission Manager, and Publisher to ensure the filing strategies are defined and executed, and requirements are met, ensuring a submission ready dossier + Keep abreast of the external regulatory environment, including competitor intelligence, local product and international regulatory and commercial strategies Qualifications: + Permanently authorized to work in the U.S., must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually requires future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship. + Currently pursuing a University degree, completing minimum undergraduate sophomore year prior to internship or co-op start date. + Availability to work on site if the position requires it. + Availability to work full time (40 h/w) for the entire co-op or internship. + Having a graduation date after the contract end date. 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.