Michele Cobham Email Address

Senior Manager

Par Pharmaceutical

My ideal goal would be something that has continually alluded me and probably will for my entire career and that is the elusive 'paperless office." It has always been a career goal to create and/or find the true paperless office. I don't think I ever will AND I do understand why it won't happen in my lifetime. So, in light of this, I have honed my expertise in the areas of automation and electronic applications. I thoroughly enjoy taking applications that for the most part have been manual applications and/or paper applications and turning them into electronic applications that are user-friendly, add value to the department or function, and everyone enjoys using. From a professional perspective within the pharmaceutical industry, I see myself in a managerial role in the electronic submissions or eCTD arena with functional responsibility for providing compliant electronic submissions to FDA. Every day I learn something new and I value that learning process very much and utilize EVERYTHING that I learn. Specialties: Excellent computer skills and knowledge; expertise, knowledge, and skills in electronic submissions, eCTD and hybrid submissions; familiarity with EDMS and Documentum; working knowledge and experience with several eCTD Publishing Tools such as CSC/ISI eCTDXpress, Global Submit Review, Validate and Publish and IBM SCORE; working experience with FDA drug listing and Daily Med using xml tools such as XForms, Quark XML Author and i4i A4L SPL/PLR software.