InternCoOp NonLDP
: Job Details :

Janssen R&D, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting an Established Products Internal Medicine/Infectious Diseases Co-Op (EP IM/ID Co-Op). Established Products (EP) is a functional area within the Global Medical Organization of Janssen Research and Development. EP isresponsible for the late lifecycle management and optimization of a variety of legacy products across a diverse group of therapeutic areas. The areas are divided into four portfolios: Internal Medicine/Infectious Diseases; CNS (includes Psychiatry, Neurology and Anesthetics); Cardiovascular/Metabolism/Pulmonary Hypertension; and Oncology.As part of the EP Strategic priorities, EP actively outreach to internal and external partners in areas of unmet medical need to collaborate in key projects addressing Global Public Health issues. The EP IM/ID Co-Op position supports the Therapeutic Area Portfolio Clinical Team 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.The EP IMID Co-Op will:* Work with the Clinical and overall EP IM/ID compound development teams (CDT) and their internal and external partners in the execution of specific tasks and projects specifically related to clinical studies and other tactical strategic activities conducted for the support of this portfolio.* Work in concert with the Clinical Leaders on clinical trial concept and protocol development, execute clinical studies for new formulations, post-approval commitments, and new indications.* Be actively involved in 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, clinical, medical and market access plans.