Principle Medical Writer

Key People

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Job ID :

15126


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


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 :

Lausanne




Job Category :

Medical Writing Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

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.

For more information,visit www.keypeople.co.uk.

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