Matawan, New Jersey, United States
Information Scientist with an extensive background in locating published biopharmaceutical and medical information to support research and regulatory affairs. Contributed to the successful launches of new HIV and RA drugs. Strong organizational, analytical, writing and communication skills with a focus on delivering quality FDA and USDA reports on time to regulatory clients thus enabling the FDA process to fast track drug development. Specialties: Coordinated, developed and delivered library services to the cardiovascular and thrombosis research teams at all US sites. Regulatory New Drug Application (NDA) and Safety Update Report (SUR) reporting. Knowledgeable of USDA animal care and use regulations as well as OSHA regulations.
Business chemical and scientific literature searching. Also responsible for the information services budget and deparmental metrics. Other responsibilities include project management, budget planning, collection development. · Competitive intelligence by analyzing patent search results, identifying trends, and performing value chain analysis in order to spot opportunities for new product development or new markets for existing products. · Library portal design and development to meet user requirements.
Coordinated, developed and delivered library services to the cardiovascular and thrombosis research teams at all US sites. Submitted formatted Regulatory New Drug Application (NDA) and Safety Update Report (SUR) search results to Regulatory and Global Pharmacovigilance and Labeling (GPL) groups. Collaborated with multidisciplinary clinical and non-clinical groups to provide current awareness alerts and competitor compound surveillance. Knowledgeable of USDA animal care and use regulations as well as OSHA regulations.
Performed biomedical, biopharmaceutical and competitive intelligence searches for the scientific and business communities.