Андрій

Andriy Maslyanko
Lviv, Ukraine, [open contact info](look above in the "contact info" section)
[open contact info](look above in the "contact info" section)
[open contact info](look above in the "contact info" section)

SUMMARY Dynamic Medical Writer with 10 years of experience in clinical documentation and medical
communications. Proven expertise in developing high-quality content and extensive
knowledge of clinical research and trials. Achievements include leading significant
regulatory submissions and authoring comprehensive clinical study protocols. Passionate
about educating the healthcare community through compelling presentations and
informative content

WORK EXPERIENCE

2021 - 2024 Medical Writer, Clinical & Medical Manager, ACINO Switzerland
 Supported and reviewed documentation for new clinical trials,
including trial protocols and study designs, ensuring compliance
with regulatory standards.
 Coordinated diverse projects outsourced to Contract Research
Organizations (CROs) and partnerships, optimizing project timelines
and deliverables.
 Actively contributed to ongoing and planned educational programs
and research related to drug development throughout the product
lifecycle. Provided input on Deficiency Letters responses and
prepared necessary medical or clinical documentation for
marketing authorization renewals. Led and managed the
preparation of scientific advice submissions to Health Authorities.
 Engaged in clinical and regulatory development projects,
contributing to strategy formulation and operational execution.
 Conducted Due Diligence and performed gap analyses concerning
bioequivalence and associated clinical study data.
 Evaluated non-clinical and clinical dossier sections, particularly
reviewing Modules 2.4/2.5 to 2.6/2.7 and Module 4 as well as
Module 5 in accordance with local country requirements.
 Participated in the enhancement of the Quality Management
System within the department, drafting new procedures and
Standard Operating Procedures (SOPs) while revising existing
documents.
2015 - 2021 Medical Writer, JSC “FARMAK” Kiev, Ukraine
 Authored clinical documentation for dossier submissions to
regulatory authorities and Ethics Committees, facilitating
permission for clinical trial implementation.
 Designed clinical trials, particularly bioequivalence studies, and
participated actively in preclinical study initiatives.
 Created comprehensive medical and pharmaceutical
documentation for registration processes across Module 2.4,
Module 2.5, Modules 2.6, Module 2.7, Module 4, and Module 5.
 Drafted clinical study protocols, protocol amendments, investigator
brochures, and informed consent forms to ensure participant safety
and compliance.
 Composed clinical journal manuscripts and abstracts for publication
in esteemed scientific journals, contributing to the body of research.
 Compiled extensive reviews of medical and scientific literature to
support ongoing research and clinical applications.
2012 - 2015 Quality Assurance Director. Qualified Person, Bio-Test-Laboratory Ltd. Kyiv, Ukraine
2011 - 2012 Senior Research Scientist, Rhodes University Grahamstown,
South Africa
2009 - 2011 Post-Doctoral Research Associate, University of Western Cape Cape Town,
South Africa
2003 - 2009 Staff Scientist, Biological Research Centre, Institute of Biochemistry Szeged, Hungary
2000 - 2002 Doctor-Laboratory Assistant (Medical Technologist, 1st category), Private Lviv, Ukraine
Medical Centre “Bio-Lab Triada”
1999 - 2000 Head of Clinical Diagnostics Laboratory, Medical Centre “Bogdan” Lviv, Ukraine
1998 - 1999 Junior Research, Research Institute of Epidemiology and Hygiene Lviv, Ukraine
nd
1997 - 1998 Doctor-Laboratory Assistant (Medical Technologist, 2 category), Lviv, Ukraine
Medical Ltd “3i”
1995 - 1997 Sales Supervisor and Consultant of the Laboratory Equipment, Medical Lviv, Ukraine
Ltd “3i”
1993 - 1995 Doctor-Laboratory Assistant (Medical Technologist, 3rd category), 5th Lviv, Ukraine
Municipal Clinical Hospital

EDUCATION

2022 - 2023 Ukrainian Military Medical Academy Kyiv, Ukraine
Diploma of Medical Technologist
2004 - 2008 University of Szeged, Biological Research Centre Szeged, Hungary
PhD student
2002 - 2003 Biological Research Centre Szeged, Hungary
ITC student
1997 - 1998 Lviv D. Halinski State National Medical University Lviv, Ukraine
Diploma of Medical Technologist
1987 – 1992 Ivan Franko National University Lviv, Ukraine
Diploma of Biologist, Human Physiologist

SKILLS Clinical trial design Quality Assurance
Clinical documentation Project management
Medical writing Communication skills
Regulatory compliance Problem-solving skills
Biochemical analysis Ability to learn new things
Analytical skills

LANGUAGES Ukrainian
English
Russian

INTERESTS Painting