PharmStatus.com - Regulatory Document Preparation

I am a former academic with 20 years of experience in drug discovery and structural biology. I am now a full time consultant and medical writer. In academia, I have written extensively on structural determination of macromolecules using NMR and theory. I frequently consulted or collaborated with scientists from various fields related to drug discovery. I write about and consult for a wide range of subjects and must keep abreast of the scientific literature and the activities of biotechnology companies. As a freelance consultant, I have been the point person to complete jobs requiring multiple types of expertise. I am committed to utilize resources creatively in order to meet or exceed deadlines while managing multiple projects. I have experience in experimental physics and engineering, computer software and programming, statistical and data analysis, and editing and publishing. I have managed teams of medical writers, hardware technicians, and students. Supervised a team of 8 MDs and PhDs to produce adverse event narratives for the safety section of Clinical Study As an academic, I taught courses to instruct graduate students on how to interpret research literature and how to present research.

• CNS
• Oncology
• Autoimmune Disease
• Pain

• Produced 900+ adverse event and special safety narratives per month for a major pharmaceutical company's FDA submissions.
• Wrote templates for special safety narratives and was responsible for the QC/QA and final edits.
• Phase III Clinical trials to assess the safety and efficacy of 4 marketed CNS medications for approval from the FDA for new indications.
• Medical Writing Project Manager for EU and FDA submission of adverse event narratives.
• Writing a wide range of documents from original peer-reviewed scientific papers to review papers and white paper to adverse event narratives for both the EU and the FDA.
• Writing portions of clinical study reports, integrated summaries, investigator brochures, and medical journal publications.
• Understanding of federal regulations and international standards (e.g. ICH).
• Supporting a diverse number of therapeutic areas.
• Supporting multinational studies.
• Participates in long-range planning; develop and manage project plans, assess resource needs, and develop and implement processes and standards.
• Participates in business plan and budget development, overall strategy for medical writing discipline, and capacity planning.
• Development and maintenance of processes, templates and SOPs.