Experience

Debiopharm

• Switzerland
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Regulatory Affairs Manager

  • Oct 2021 - Present



Freelance

• Regulatory affairs and Medical Writing consultant

  • Aug 2021 - Oct 2021



Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)

• Italy
• Research Services
• 1 - 100 Employee

• Medical Writer Regulatory

  • Nov 2019 - Aug 2021

  – Preparation of IMPD/IMDD/ATMP review and edition of country specific documentation (protocols, summary, questionnaires, IB, PIA etc.); – Clinical Trial application to EC and CA (France, Italy, Austria, Denmark, Germany, Spain, UK); Communication with research sites, EC, CA; – Providing of regulatory replies, preparation of regulatory strategy for trials on Medicinal products, Med Device, ATMP; – Research site contracts preparation, edition, negotiation; – Safety reports writing and revision; – Safety signal assessment and risk management strategies; – Scientific writing and publications: bibliographic research, edition and proof reading of publications, guidelines that aim to be submitted to the European Commission.; – Education materials for regulatory and QC/QA team (presentations, guides, SOPs). Projects: Conect4Children - collaborative pan-European network aiming to optimise the delivery of clinical trials in children. Functions within the project: Scientific Contributor Area: pediatrics, rare disease, immunology (Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriasis), hematology.



Medicine and pharmaceutical

• Medical Writer

  • Apr 2015 - Nov 2019

  – drug and disease-related documentation (elaboration and edition); – drug related educational material (elaboration and edition); – healthcare web content (elaboration); – regulatory documentation (edition). Visit https://pharmacg.home.blog/ to see examples of my work. – drug and disease-related documentation (elaboration and edition); – drug related educational material (elaboration and edition); – healthcare web content (elaboration); – regulatory documentation (edition). Visit https://pharmacg.home.blog/ to see examples of my work.



Acino

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control

  • Jul 2017 - Feb 2018

  Quality control management (internship) Pharma Start LLC, Acino Group Switzerland, Boulevard Lepse Ivana, 8, city of Kiyv, 03124, Ukraine Contact person: Anton Sikorskyi –Head of Quality Control department – Anton.Sikorskyi@acino.swiss Main activities and responsibilities: development and maintenance of internal documentation according to GMP. Participation in CAPA system projects for QC department, organisation of QC laboratory work, validation and revalidation of laboratory analytical equipment such as chromatograph(HPLC and GC), mass-, IR-spectrophotometer, equipment for dissolution test. Sector: Pharmaceuticals, Biotechnology, Medicine.



Biotexcom

• Kiev

• Freelance Medical Writer

  • May 2015 - Aug 2017

  Digital marketing manager Biotexcom reproductive clinic, Otto Shmidt street 2/6, 04107 Kiev, Ukraine http://ua.biotex.com.ua/ Main activities and responsibilities: medical writing, research of potential clients, monitoring of actual situation in reproductive medicine sector, copyrighting. Sector: Medicine. Digital marketing manager Biotexcom reproductive clinic, Otto Shmidt street 2/6, 04107 Kiev, Ukraine http://ua.biotex.com.ua/ Main activities and responsibilities: medical writing, research of potential clients, monitoring of actual situation in reproductive medicine sector, copyrighting. Sector: Medicine.



THEMEDIAWAY

• Ukraine
• IT Services and IT Consulting
• 1 - 100 Employee

• Didgital marketing manager (junior)

  • Dec 2015 - Aug 2016

  Digital marketing manager (Junior) THEMEDIAWAY, Yohann Bourbao, Dilova street 5B, 03150 Kiev, Ukraine http://www.themediaway.com/ Main activities and responsibilities: research of potential clients, realisation of marketing strategy, promotion of company’s services, prospection and realization of market studies, management of client’s information. Sector: Digital marketing Digital marketing manager (Junior) THEMEDIAWAY, Yohann Bourbao, Dilova street 5B, 03150 Kiev, Ukraine http://www.themediaway.com/ Main activities and responsibilities: research of potential clients, realisation of marketing strategy, promotion of company’s services, prospection and realization of market studies, management of client’s information. Sector: Digital marketing