Regulatory Affairs Internship, Summer 2021
Posted on Apr 6, 2021 by Johnson & Johnson
At Johnson & Johnson, we use technology and the power of teamwork to discover new ways to prevent and overcome the world's the most significant healthcare challenges. Our Corporate, Consumer Health, Medical Devices, and Pharmaceutical teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and medicines. Were disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives. With a reach of more than a billion people every day, there's no limit to the impact you can make here. Are you ready to reimagine healthcare?
Here, your career breakthroughs will change the future of health, in all the best ways. And you'll change, too. You'll be inspired, and you'll inspire people across the world to change how they care for themselves and those they love. Amplify your impact. Join us!
Internship Experiences Include:
Global Medical Safety Operations:
Case Processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
Prioritization of incoming cases for daily workflow management
Completion of case data entry (including narrative or auto-narrative), manual coding, label, and approval
Collaborate closely with Global Case Receipt and/or Global Medical Safety Operations Physicians (GMSOP) staff as appropriate to clarify appropriate information required for case processing
Completion of all assigned training on the company and GMSO procedural documents relating to case processing
Completion of training relating to relevant Pharmacovigilance (PV) Agreements for assigned product
Participate in designated activities to support revision/creation of case processing procedural documents
Medical Devices Regulatory Affairs:
Assist in the compilation of requirements for global regulatory submissions of our products
Support the transition of files to applicable Global Medical Device Regulations
Attend project team meetings with RA lead to assist in strategic discussions to hone team collaboration skillset
Learn regulatory affairs competencies to ensure product registration lifecycle processes compliance
Evaluate current processes and propose opportunities for efficiencies/improvements
Pharmaceutical Global Regulatory Affairs:
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 and combination products.
Use creative problem solving skillsets, to develop new ideas and insights, including takeaways about yourself as a leader.
Partner with other regulatory interns with diverse skills and experiences in building solutions for real-life business challenges through hands-on projects.
Experience compound development functions and regulatory affairs groups in the other J&J business sectors (such as Medical Devices and/or Consumer Products).
Experience/interest in graphic or visual design, journalism, creative writing, or creative arts is a plus.
Currently enrolled Full time and have completed at least 2 years in an undergraduate program, or enrolled Full time in a graduate program (M.S., M.E., Ph.D. or M.D.), pursuing a degree majoring in a scientific, technology or engineering related field. Examples include, biomedical engineering, data analytics/applied statistics, quantitative modeling in biology, pharmacy, life Sciences, medical/scientific writing or public health administration
Candidate must be legally authorized to work in the United States and not require sponsorship for employment visa status (eg H1-B status) now or in the future.
Available to work Full time (40 hours per week) during internship (May-August).
Candidates need to be proficient with Microsoft Office, Word, Excel (including a high proficiency with generating pivot tables and graphs), and Power Point, and have strong oral and written communication skills. Additional technical competencies in SharePoint, Teams and other information technology systems are highly desirable.
Able to work individually, as well as, part of a group, with curiosity and flexibility.
Possess a can do approach, and courage to speak your voice and suggest innovative ideas.
Assignment location will be remote.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.