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 is responsible 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.
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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.
Qualifications
Qualifications
• Candidates must be enrolled in an accredited college/university pursuing MD, PhD, Pharm D or any other health care related advanced degree, with emphasis in Biological sciences and Public Health.
• Bachelor's degree in the Biological Sciences with strong clinical experience or preferably possessing or enrolled in a Master's degree in a Clinical Science or a related field or Paramedical (Allied Health care) professionals (including nurse practitioners, physician's assistants and midwifes) with strong clinical/research background would be considered.
• Previous experience in development and/or execution of phase 2-3 clinical studies and strong background in clinical pharmacology and/or internal medicine/infectious diseases is desirable.
• Candidate should be passionate about science & operational excellence.
• Candidate should possess strong problem-solving skills for developing creative solutions and meeting project objectives.
• Candidate should have demonstrated ability of strategic thinking and contingency planning with respect to project objectives.
• Candidates must be available to work Full Time and available for the total duration of the role (6 months)
• Candidates must be legally authorized to work in the United States and not require sponsorship for employment visa status (e.g. H1-B status) now or in the future.
• Demonstrated leadership is preferred.
• Candidates must be detail-oriented, highly organized and able to manage multiple tasks while maintaining a strong sense of urgency.
• Candidates must have the ability to work individually (independently) as well as on a matrix team.
• Candidate should possess strong interpersonal skills and be able to work effectively in a collaborative team environment
• Candidates must be proficient with Microsoft Office, Word, Excel (including a high proficiency with generating pivot tables and graphs), and Power Point, and must have strong oral and outstanding written communication skills. Additional technical competencies in SharePoint and other information technology systems are highly desirable, as is experience with PubMed databases and other literature databases.
• Candidates with experience working on academics and/or industry clinical trials and/or in areas of Global Public Health particularly in underdeveloped countries are strongly preferred.
• A minimum G.P.A. of 3.0 is strongly preferred.
• Participation in campus/community service activities is desired.