Medical Writer

з/п не указана

Вакансия в архиве

Работодатель, вероятно, уже нашел нужного кандидата и больше не принимает отклики на эту вакансию

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Требуемый опыт работы: 1–3 года

Полная занятость, полный день

Key Accountabilities:

  • Writing, editing and review of clinical documents, including, clinical development plans, study synopses, investigator brochures, study protocols, informed consent forms, patient information, interim and final clinical study reports, safety update/aggregate reports, and other project-specific clinical documentation;
  • Ensuring quality and compliance of essential study documents with applicable QSDs, pertinent regulatory requirements, and client specifications;
  • Serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues;
  • Consulting study team on the study protocol related questions;
  • Collaboration with statisticians and data managers regarding sample size estimation, data issues and data analysis, review of SAPs and TFLs, participation in data listings review;
  • Reviewing scientific literature pertinent to medical writing activities;
  • Coordinating production and distribution of draft and final documents to project team and client;
  • Participation in local and international medical writing conferences and trainings;


Qualifications and skills:

  • Experience in writing scientific or clinical study documents: articles, scientific works, protocols, IBs, ICFs, clinical study reports is a plus;
  • Basic knowledge and understanding of statistics;
  • Excellent interpersonal, verbal and written communication skills;
  • Client focused approach to work;
  • Understanding of clinical research, the drug development process, and applicable regulatory guidelines;
  • Degree in Medicine or Life Sciences; PhD or Dr of Medical Sciences;
  • Fluency in English (written and spoken) is required;

Адрес

Санкт-Петербург, Ковенский переулок, 5
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Вакансия опубликована 26 июля 2019 в Санкт-Петербурге

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