DR. MARIA O’ROURKE

Dr. Nekowitsch Strasse 71/2, A-1210 Vienna, Austria.
office@morourke.eu +43 681 84152185 www.morourke.eu

Consultant scientific and medical writer, with a solid background in preclinical and clinical R & D and substantial experience in Medical Writing covering regulatory submission documents for medical products and devices across multiple therapeutic areas.

EXPERIENCE

Consultant Medical Writer, Director (Owner) MOR Medical Writing, Vienna, Austria.
April 2020 to present

Senior Clinical Research Scientist, AXON Neuroscience, Slovakia/ Austria (Office/ Home Office)
August 2016 to January 2020

  • Key participation in study design, scientific input and data presentation in the field of Alzheimer’s Disease, Frontotemporal Dementia.
  • Responsible for the clinical development plan and target product profile for AADvac1, Scientific Advice (EMA) and IND (Modules 1, 2, 4, 5).
  • Responsible for writing and reviewing clinical submission documents, for data analysis and posting results to regulatory agencies and ECs.

Manager Medical Writing, CROMA Pharma, Austria.
October 2014 to July 2016

  • Key participation in the design & development of clinical trials for medical devices and products in the fields of Aesthetics, Opthalmology and Orthopaedics.
  • Responsible for writing clinical submission documents for devices (CERs, Clinical Investigation plans/reports, PMCF plans/reports, IFU, DRiA, Risk Management, publications) and for medical products (Phase 3 protocol, CTD Module 2, IB, Scientific Advice EMA/FDA).
  • Responsible for providing feedback to regulatory authorities and Notified Bodies and providing authoritative technical advice to customers (complaints/ queries).

Manager Medical Writing, Clinical R & D, Baxter, Austria.
August 2011 to Sept. 2014

  • Responsible for writing clinical submission documents for medical products/biologics across diverse Therapeutic Areas (Vaccines, Haemophilia, Biotherapeutics and Biosurgery). Documents written for Phase 1/2 and several Phase 3 studies for BLA, MAA/NDA. Protocols/Amendments, IBs, DSURs, CSRs, Clinical Overviews, Clinical Summaries, ISS, ISE and publications.

Group Leader, Vaccine R & D, at Baxter, Austria.
May 2001 to July 2011

  • Responsible for the planning and direction of R & D, staff hiring & supervision. Multiple projects investigated. The principal project, from initiation to Phase 3, was the development of a vaccine against Lyme Borreliosis.
  • Primary KOL contact for development of methods to determine vaccine efficacy.
  • Responsible for writing highly technical scientific regulatory documents (Sections of IMPD & Drug Master File, IND-relevant reports, Scientific Advice, Investigator’s Brochures and study packages for outsourcing to CROs).
  • Patent preparation and review of all competitive external patent claims.
  • Involved in due diligence activities (pre-clinical).

Post-doctoral Research Associate, Bacterial Vaccine Development, Baxter, Austria.
June 1996 to April 2001

  • Active R & D to identify vaccine targets and develop methods and assays.
  • Molecular epidemiology studies performed, target genes cloned and recombinant proteins expressed, cell banks prepared, protective potency & immunogenicity demonstrated in animal models, real-time PCR assays developed and validated.

Post-doctoral fellow Molecular Genetics Group, University of Sussex, UK.
Oct. 1992 to April 1996

  • Conducted research in Molecular Evolution & Epidemiology in Pathogenic Neisseria.
  • Developed a technique for the epidemiological typing of N. gonorrhoeae (opa typing), which is a marker for HIV spread, used by St. Mary’s Hospital, London.
  • Lectured and supervised graduate and M.Sc. students.

 

EDUCATION

Degree in Natural Sciences II, TRINITY COLLEGE, DUBLIN, IRELAND.
Oct. 1983 to June 1987
Conferred with a B.A.Mod in Medical Microbiology. Thesis title “Analysis of extracellular polypeptides among S. aureus isolates associated with Toxic Shock Syndrome”.

Ph.D. in Microbiology. NATIONAL UNIVERSITY OF IRELAND, GALWAY, IRELAND.
Jan. 1988 to May 1992
Thesis title “Analysis of the Genetic Structure of Populations of Neisseria gonorrhoeae”. Part of the research was carried out at Harborview Medical Center, Washington University, Seattle, US.

 

ADDITIONAL SKILLS

  • Excellent working knowledge of pharmaceutical regulations, ICH & FDA guidelines, codes of practice and relevant EMA, CBER and CDER Guidelines.
  • Proficiency with Microsoft Word, Access, Excel, PowerPoint, EndNote.
  • Language skills: English native speaker and fluent German.
  • Extensive training covering GMP, GLP, Test Validation and Management essentials.

 

PUBLICATIONS AND PATENTS