Barb James

Background

About Barb James

Pharmaceutical industry medical/scientific professional with approximately 15 years experience in both field-based and in-house scientific positions. Broad knowledge base spanning several therapeutic areas including the following: immunology, anti-infective, renal, gastrointestinal, women's health, and neurology/CNS. Experienced in the development and delivery of education/training to both internal and external stakeholders. Highly proficient in analyzing, interpreting, and presenting complex clinical data in an easy to understand manner, whether via slide presentations, informal discussions, medical letters, or written responses. Have represented Medical Affairs as a Senior leader in conducting due diligence on multidisciplinary global product support teams, such as periodic safety teams (PSTs) and labeling sub-teams (LSTs), as well as in providing medical perspective on advertising and promotional review materials. Skilled in engaging KOLs and HCPs to assess interests, educational needs, research ideas/needs, and merits/limitations of available therapies and studies. Familiar with pharmaceutical regulations as related to medical information, advertising/promotional review, safety reporting, and health authority requirements.