Dmitriy Usenko

About Dmitriy Usenko

Clinician with 13 years of experience in developing and implementing clinical research in…

Experience

1. Medical Writer

   Theradex Oncology

   Jan 2019 — Present

   Lead the development and authoring of Initial Investigational New Drug (IND) applications and amendments, clinical study protocols and protocol amendments, Investigator’s Brochures, interim and final clinical study reports, IND annual reports, clinical summaries in support of regulatory filings and additional documents intended for submission to the FDA and EMA. Assist in designing protocol strategy and writing the synopsis and background section of clinical study protocols. Prepare patient narratives. Support development of scientific meeting abstracts, posters, and oral presentations of clinical study data for submission to medical congresses and primary manuscripts for submission and publication in peer-reviewed journals. Interact with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs. Provide guidance and support to other in-house units in preparation or review of manuals, training guidelines and similar documents. Interact with regulatory groups and internal auditing groups, proactively managing cross-functional input. Organize, conduct, and lead cross-functional document development meetings.

Education

• Kharkiv National Medical University, 2003

  M.D, Medicine

  1997 — 2003

• Kharkiv Medical Academy of Postgraduate Education

  Doctor of Medicine (MD), Residency in Anesthesiology and Intensive Care Medicine

  2003 — 2005

Skills

• Clinical Trials
• Management
• Good Clinical Practice (Gcp)
• Biotechnology
• Clinical Research
• Medical Devices
• Clinical Monitoring
• Cancer
• Hospitals
• Icu
• Research
• Lifesciences
• Therapeutic Areas
• Pharmaceutical Industry
• Healthcare
• Clinical Development
• Oncology
• Medicine
• Treatment
• Internal Medicine