James Burrus

About James Burrus

Specialties: A dynamic leader with extensive experience in Regulatory Affairs (Advertising and Promotion), Healthcare Compliance, Pharmaceutical Sales and Marketing. Therapeutic area experience Oncology. Gastrointestinal, CNS(Psychaitry & Neurology), Pain, Anti-Infective, and Virology

Experience

1. Director, Regulatory Affairs (Advertising Promotion), & Healthcare Compliance, Oncology

   Johnson & Johnson

   Aug 2003 — Present

   As part of a multi-disiplinary team of marketing, legal, regulatory and medical, I am responsible for the review and approval of professional and consumer communications in accordance with all applicable FDA regulations (21CFR 202.1 et al) in addition to any applicable corporate guidelines. Serves as a point of contact for FDA\'s Office of Prescription Drug Promomotion (OPDP). Additionally, provides consult during product development including the Target Product Profile, Phase II through Phase IV studies to support expected product claims. Participant in product labeling teams. Currently responsible for Oncology therapeutic area. Past products include Prilosec, Nexium, Risperdal, Risperdal Consta, Aciphex, Invega, Sylvant, Invega Sustenna, Razadyne ER, Duragesic, ReoPro, Procrit, Vivotif and Doxil. Oncology product oversight include Zytiga, Yondelis, Darzalex, Darzalex Faspro, Erleada, Balversa, Carvykti, Procrit, Rybrevant, Imbruvica and P1-P3 compounds in development. Accelerated approval Subpart E and H indications and products.Advertising and Promotion Real World Evidence Lead Certification in Healthcare Compliance from Seaton Hall.

Education

• University of Kentucky

  BS, Microbiology

Skills

• Clinical Trials
• Clinical Development
• Regulatory Affairs
• Cross-Functional Team Leadership
• Drug Development
• Advertising
• U.s. Food and Drug Administration (Fda)
• Medicine
• Pharmaceutical Industry
• Fda
• Pharmaceutical Sales
• Neurology
• Oncology