Clinically and medically astute scientific research professional with a unique background that includes over 22 years of experience in the pharmaceutical and biotech industries. With 16 years of Medical Affairs experience. Well versed in pre-clinical and clinical research, compliance, and regulatory matters. Over 8 years of field-based Medical Science Liaison experience in Protein Conformational Neurodegenerative Diseases (PCND) including Alzheimer’s Disease (AD), Parkinson’s disease (PD) and Orphan and rare diseases such as Multiple System Atrophy (MSA) as well as Autoimmune Diseases and cardiovascular diseases. Extensive knowledge and training in clinical trials. Well-versed in FDA and International Regulatory rules such as ICH E6, 21 CFR Part 11 and 21 CFR Part 50. Participated and contributed to the full process of drug development from target identification to phase 4 clinical trial post NDA approval by FDA.
Accomplished speaker and presenter with demonstrated ability to build high profile relationships with healthcare professionals (HCPs), key opinion leaders (KOLs) and Stakeholders across multiple therapeutic areas. Skilled at managing cross-functional relationships and spearheading initiatives to accomplish business goals. Team builder.
Well-versed in FDA, OIG requirements and Knowledge of the PhRMA code of conduct, the Sunshine Act, and HIPAA regulations., Pharmaceutical /Medical Affairs/ Medical Science Liaison/ Clinical Trials, phamacautical, phamacautical