Вакансії: director of regulatory affairs, Київ
- Discovery Laboratories (Ukraine)Київ·
- Initiation of expansion of areas of cooperation with existing sites and attraction of new sites:
- Coordination of expansion and implementation of goals;
- Переглянути всі Вакансії - Discovery Laboratories (Ukraine) — Вакансії в локації Київ — Вакансії - Feasibility Manager, Київ, Київ
- Пошук зарплат: Manager Clinical Affairs and Feasibility
- Teva PharmaceuticalsКиїв·
- In-depth knowledge of the Ukrainian healthcare system, including government bodies and regulatory institutions;
- Fluent in English and Ukrainian;
- Переглянути всі Вакансії - Teva Pharmaceuticals — Вакансії в локації Київ — Вакансії - Director of Regulatory Affairs, Київ, Київ
- Пошук зарплат: Associate Director Government Affairs
- Перегляньте популярні запитання й відповіді про компанію Teva Pharmaceuticals
Job Post Details
Опис вакансії
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Повний опис вакансії
About Discovery Life Sciences:
Discovery Life Sciences is a trusted provider of bioanalytic and biospecimen services to hundreds of customers across the U.S. and around the world. The Director, Business Development Proteomics role contributes to our mission by consistently closing new and repeat proteomic lab services business from customer accounts in an assigned territory.
Position Summary:
Manager Clinical Affairs and Feasibility contributes to our mission by overseeing the full technical coordination of the site for research protocols, including obtaining regulatory permits and forming the research team. The role ensures the site has necessary equipment and consumables, train the research team, and launch projects while maintaining quality and quantitative indicators. The role also organizes logistics workflow, conducts regular monitoring and audits, and works on analytical reporting to evaluate site effectiveness. Additionally, the role performs as technical expert in Feasibility process for internal and external clients and to provide strategic input to Business Development.
Position Qualifications (Education, Skills, Experience):
- Higher education in medical field
- work experience in the field of health care, and/or in the pharmaceutical industry for Rx, in the field of clinical research from 3 years, in the role of medical coordinator for projects;
- Solid knowledge of clinical network in Ukraine, preferable non-onco
- English language from the upper-Intermediate; Ukrainian - fluent
- understanding the basics of project management;
- analytical thinking, the ability to systematize large volumes of information
- experience working with information systems,
- PC at the level of an advanced user
Key Responsibilities:
- Full technical coordination of the site in the organization and implementation of research protocols:
- Clinical site support for obtaining the necessary regulatory permits and relevant documents;
- Participation in the selection and formation of a research team on the site;
- Providing the site with the necessary medical/technical equipment;
- Providing the site with the necessary consumables;
- Preparation (training) of the research team to participate in the study;
- Launch of projects (research) and ensuring the planned implementation of quantitative indicators;
- Ensuring the planned implementation of quality indicators;
- Organization of logistics workflow in the coordination of the site;
- Conducting regular monitoring and audits of the site for the proper implementation of the study.
- Work with analytical reporting and planning:
- Formation of reports on the effectiveness of the site, analysis of quantitative and qualitative indicators;
- Preparation of reports for presentation of site performance indicators to the research team;
- Participation in the planning and development of processes, algorithms, instructions aimed at optimizing the production process within the unit.
- Coordination of expansion and implementation of goals;
- Perform as technical expert in Feasibility process for internal and external clients and to provide strategic input to Business Development Operations to Sponsors, specifically for non-onco projects with clear understanding of patient flows and referral pathways in support of global/local operational delivery
- Initiation of expansion of areas of cooperation with existing sites and attraction of new sites:
- Expansion of cooperation with the site by attracting new branches: negotiations, organizational and technical support.