EP Immunology/CVM-PH Clinical Co-Op

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.

Key Responsibilities

Work with the Clinical and overall IMM/CP compound development teams (CDT) and their internal and external partners in the execution of specific tasks and projects in IMM/CP related to clinical studies, pediatric development, and strategic activities conducted for the support of this portfolio.


* 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.

Education


* 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.

Experience and Skills

Required:


* 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 inp...