Medical writer in YuRiYa-FARM, Farmacevtichna Korporaciya

YURIA-PHARM is a Ukrainian pharmaceutical group of companies that owns the largest area of ​​production facilities in Ukraine. We already operate in more than 50 countries and have ambitious goals to enter the TOP 100 global pharmaceutical companies.

Today, in the conditions of martial law, without stopping for a single day, we continue to provide both the civilian population and the Armed Forces with essential medicines and medical products.

We invite you to the team Medical writer.

 We offer:

• official employment;

• competitive salary and annual bonus based on work results;

• safe and modern office, free meals;

• laptop, corporate mobile communication;

• annual leave lasting 30 calendar days, instead of 24 according to the Labor Code;

• material assistance in various life situations;

• career growth and corporate development programs.

Main tasks:

• development and management of documentation taking into account various regulatory requirements;

• formation and updating of the preclinical and clinical part of the registration dossier for drugs (medicinal products) (sections of Module 2, namely 2.2, 2.4, 2.5, 2.6, 2.7, and Modules 4 and 5) in the format of a Common Technical Document (CTD) or in accordance with the requirements of the regulatory legal acts of other countries;

• development and updating of the Risk Management Plan and Regularly Updated Safety Report, preparation of Appendices to Clinical Review and Summaries;

• development and updating of instructions for the use of pharmaceuticals during the life cycle, taking into account the regulatory requirements of Ukraine and other countries of presence;

• forming a response to the comments of the regulatory authorities of Ukraine and other countries to the preclinical and clinical part of the materials of RD on drugs;

• carrying out a literature search and analyzing information on the preclinical and clinical evidence base of products;

• communications with other structural divisions;

• work with change protocols and internal plans-schedules for state registration (re-registration) and making changes to registration materials during the validity of the vehicle registration certificate

Knowledge and skills required:

• higher medical, biological, pharmaceutical education;

• experiencework in writing: preclinical/clinical part of RD (modules 2, 4, 5) for different types of applications; instructions for the medical use of medicinal products; Risk Management Plan and Regularly Updated Safety Report, Addendums to Clinical Review and Summaries;

• knowledge: ORDER dated 08/26/2005 No. 426 On approval of the Procedure forconducting examination of registration materials for medicinal products submitted for state registration (re-registration), as well as examination of materials on changes to registration materials during the validity of the registration certificate; Directive 2001/83/EC; Volume 2B Notice to Applicants Medicinal products for human use Common Technical Document (CTD);

• English language: upper intermediate level (possibility of working with English-language documents and writing documentation in English)

Life is the main earthly value. Join our team to create unique solutions, thereby preserving and improving it!