Colin Mansfield

Background

About Colin Mansfield

CAREER OVERVIEW: Medical writer working on a highly diverse range of projects including medical communications, clinical study documentation, regulatory affairs documentation and patent protection. Current focus is on medical communications, Marketing Authorization Application (EMA, FDA), and intellectual property. This typically involves collaboration with the principal investigator/client to establish initial document direction, outline and target audience; preparing full drafts based upon (pre)clinical data and according to appropriate guidelines; coordinating quality control in collaboration with clinical project managers, biostats, pharmacovigilance, and marketing departments; incorporating author feedback prior to submission; execution of specific submission processes; rebuttals and revisions in response to Reviewer / Rapporteur / Examiner comments. Previously I worked as a research scientist primarily in the fields of biomedical infrared spectroscopy and microfluidic diagnostic technologies. Specialties: Writing experience in many therapy areas and scientific disciplines; including, oncology, immune-mediated diseases, neurological disorders, veterinary medicine, targeted therapies, tyrosine kinase inhibitors, infrared spectroscopy, imaging, microfluidics, lab-on-a-chip, and nanobiotechnologies. PROFESSIONAL Principal Medical Writer Patent Writer ** Scientific Editor * Post-doctoral Research Scientist Adaptability, self-reliance and teamwork are evident in the breadth of medical/scientific communication tasks undertaken and the variety of senior and junior staff collaborations