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Principle Medical WriterRef: DT22908

Salary:€100000 - €125000 per annum

Added:15 May 2019

Region: Europe

Sector: Pharmaceutical

Sub Sector: Clinical Research

The Medical Writer develops study protocols/amendments, informed consent forms (ICFs), clinical study reports (CSRs) and Investigator's Brochures (IBs) ensuring compliance with international requirements and manages the process of reviews, reconciliation of comments and document finalisation/approval. The Medical Writer works towards the timely development of these documents in agreement with deadlines set together with the Study Team and the Medical Director. Your Main responsibilities: *Author and/or update clinical study protocols/amendments, ICFs, CSRs and IBs, as required for each individual project; the documents should be accurate, suited for the intended audience and easy to read. Responsible for triggering annual IB reviews and potential updates. *Collaborate closely with internal specialists/colleagues/departments to obtain/provide information, ensure smooth review process, incorporate editorial comments, and solve queries to present a 'finished' final document within the required deadline. *Ensure understanding and implementation of international quality standards (ICH GCP) and company procedures and quality standards. Your profile: *Experienced in writing protocols/amendments, briefing books, Health Authority re-sponses, IBs, CSRs, ICFs. *Self-starter, flexible, able to adapt quickly in a fast-moving environment. *Ability to understand the purpose and requirements of a project. *Good command of the English language and solid writing/editorial skills (understanda-ble, at a level appropriate to the audience and the project). *Knowledge of science or an aptitude for understanding it, including the ability to learn new therapeutic areas quickly. Familiarity with medical terminology. *Ability to interpret and present data in a logical manner. *Ability to work within team, as well as independently. *Good time management skills and able to meet deadlines. *Attention to detail, accuracy, and logical organisation.

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