Neil Schofield

Background

About Neil Schofield

Scientist, medical writer, and team leader with proven track record of success in the biotech/pharma industry Extensive experience in drug development and research within top flight academic institutions, R&D, clinical operations, and regulatory departments Ability to analyze complex clinical data and interpret results in light of study objectives Proven experience building relationships with clinical investigators/ key opinion leaders (eg advisory boards, manuscript planning meetings, etc) Effective project manager with the skills required to handle multiple projects at the same time Extensive verbal and written communication skills Knowledge of ICH, GCP and global regulatory agency (FDA, EMEA, SFDA) guidelines and regulations pertaining to the production and submission of documents for license applications Knowledge of major regulatory submission requirements (orphan drug applications, NDA [NCE, 505(b)2], INDs, IMPDs, CTAs, CTX, etc) Highly computer literate: MS Word, Excel, PowerPoint, Project, Adobe suite software, ISI authoring templates, EDMS Documentum, Reference Manager Critical thinker, problem solver and independent worker with a focus on the company bottom-line Specialties: THERAPEUTIC AREA EXPERIENCE: Oncology (pancreatic, NSCLC, melanoma, breast); Hematology (Myeloma)/hemophilia; Cardiovascular/hemostasis (CABG, surgical sealants, stents); Trauma surgery/skin grafting/ plastics; Immunology/antibody therapies/vaccines (primary immune deficiency, protein C deficiency, influenza); and Pulmonology /critical care.