EP Immunology/CVM-PH Clinical Co-Op - 6 months internship | Start date Jan 27th - June 2025

Janssen R&D, LLC is recruiting for an Established Products Immunology/Cardiopulmonary (IMM/CP) Clinical Co-Op based in Titusville NJ.

Established Products (EP) is a functional area within the Office of the Chief Medical Officer of J&J Innovative Medicine. EP is responsible for the late lifecycle management and optimization of a variety of legacy products across a diverse group of therapeutic areas.

The EP (IMM/CP) Clinical Co-Op position supports the Therapeutic Area Portfolio Clinical and Compound Development Teams and is dedicated to maximizing the value of this portfolio through the execution of all phases of clinical development and in particular, provides active medical and scientific contribution to cross-functional clinical teams to support successful completion of clinical projects and deliverables that enable worldwide registrations for new indications, enhancements to the label and compliance with regulatory commitments for products in the market and in development.

• Work in concert with the EP Clinical and Medical Affairs Leaders on clinical trial and Real World Evidence (RWE) concept and protocol development, execute clinical studies for new formulations, post-approval commitments, and new indications.
• Be actively involved in the creation of Clinical Study Reports (CSRs), publication of clinical research findings, and presentations to relevant FDA, EMA, or other Health Authorities, advisory committees, and review meetings.
• Participate in cross-functional teams for evaluation of new product ideas and related new technologies; review medical literature, and clinical, medical, and market access plans.

• You are enrolled in an accredited college/university pursuing MD, PhD, Pharm D or any other healthcare-related advanced degree, with emphasis in Immunological Disorders (Rheumatology, GI and/or Dermatology areas) and/or Diabetes, and/or Pulmonary Hypertension or related fields.
• Bachelor's degree in the Biological Sciences with strong clinical and/or research experience in clinical, and medical areas and preferably in the IMM/CP Therapeutic Areas.

• You are passionate about science & operational excellence.
• You have strong problem-solving skills for developing solutions and meeting project objectives.
• You have demonstrated ability of critical thinking and prioritization with respect to project objectives.
• You should have a demonstrated track record of possessing an ability to innovate and generate change and solution-oriented input to address challenges in the work place and/or academia.
• You are detail-oriented, highly organized and able to manage multiple tasks while maintaining a strong sense of urgency.
• You possess good interpersonal skills and are able to work effectively in a collaborative team environment.
• You are proficient with Microsoft Office, Word, Excel, Power Point and SharePoint.
• You must be able to embrace diversity and collaboration in the workplace with an open-minded and collaborative approach.

• Demonstrated project leadership experience is preferred.
• Demonstrated experience working on phase 2-4 industry trials and/or in Medical Affairs strongly preferred.
• Proven experience in Epidemiology particularly in research activities in RWE a plus.
• Experience searching, reviewing, and summarizing outputs from PubMed databases and other literature databases is highly desirable.
• We strongly prefer a minimum G.P.A. of 3.2

• Demonstrating strong oral and outstanding written communication skills is a plus!
• Availability to work Full Time, onsite in Titusville NJ and for the total duration of the co-op is required.
• Being legally authorized to work in the United States and not requiring sponsorship for employment visa status (e.g. H1-B status) now or in the future is required.