Pharmaceutical: Drug Development and Deliverables, Project Management, Global Clinical Researcher, Medical Writing in Various Platforms, Provide Drug Product Reviews and Statistics ConsultingPharmaceutical development and deliverables: Print modules, slide decks, annotated prescribing information, storyboards for digital media for use in the training of sales force and medical science liaisons. Medical literature identification and interpretation, clinical studies, therapeutic guidelines, prescribing Information, and market research. Drug products evaluation, drug statics and author of technical medical reports. Project proposals and...

Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...