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Freelance Medical Law more...
Category: Legal
Description: I am an MD, PhD with a long experience of basic science and clinical research, including project management, budgeting, from both the pharmacological and device industry. While obtaining my MBA I started a small medical consulting firm.  The services I provide are;
1. Development of Phase I to Phase IV protocols, timeline, budgets, venues for publications, IRB presentations, IND and IDE applications
2. Medical Writing, development and editing of manuscripts, slide kits, monographs, newsletters, posters, and marketing materials. I review potential scientific journal publications, national and international authors, for accuracy of grammar, content, and consistency of message points. I ensure that publications, graphics, slide presentations, and medical education instruments meet compliance guidelines for academia and industry.
3. Adverse advents monitoring for reportability, reviewing narratives and case reports to ensure appropriateness of medical content, coding, and assessment of reporting requirements.  
4. Regulatory requirements for class I to III devices within the US and internationally, reports, amendments to protocols, labeling changes, and other safety and regulatory matters.
5. Grant applications for both research and non-profit organisations
6. Strategic analysis of industry trends and implications, monitoring of product developments and preferences, exploring competitive landscapes, and emerging technologies.  Monitoring of industry developments and CME payment trends.
Skills: US Regulatory Affairs, EU Regulatory Affairs, International Regulatory Affairs, Medical Device Industry, National and International Clinical Study Design, International Study Conduct, Scientific Publications, Medical writing
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