Principle Medical Writer

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

Western Europe,--Lausanne,Lausanne,

Key Skills :

medical writing, clinical writing, clinical trials

Salary :

€100000 - €125000 per annum

Date Posted :

18 Jul, 2019

Company Name :

Key People

Location1 :


Job Category :

Medical Writing Jobs

Experience :


Job Type:


Travel Amount:



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.

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

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