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AX-7161 Medical Writer

AXESS Published: 31st October 2018
Location
Buckinghamshire, United Kingdom
Job Type

Description

Ref: AX-7161

 

JOB SUMMARY

Opportunity for an experienced Medical Writer to join an exciting Global Pharmaceutical Organisation based to the West of London. The role focuses on Clinical Development and will require you to have previous experience and also a strong knowledge of the full clinical trial process. This is a very visible role in a highly dynamic and collaborative organisation. Office Based.

 

BACKGROUND

Global pharmaceutical Company

Broad responsibilities including life cycle medical writing, focusing on clinical development

Strong working environment, functionally very collaborative

Office based to the West of London, M4 M40 Corridor close to the M25

 

PRIMARY DUTIES

Reporting to the Head of Medical Writing, the Medical Writer will be responsible for the production of a range of medical and regulatory documents to support the company’s portfolio of drugs in development. The Medical Writer will also act as a key liaison to external providers to ensure production of high quality and appropriate scientific documents. Furthermore, they will be responsible for the maintenance of medical and regulatory documents for use in submissions.

Documentation will include:

Clinical Study Protocols

High level documents for regulatory submissions

Integrated Clinical Study Reports

Integrated reports of combined data sets

Investigator Brochures

Paediatric Investigation Plans

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

Demonstrable medical writing experience in the pharmaceutical industry

Proven experience of the management of external service providers for medical writing tasks

A detailed understanding of regulatory requirements for submissions in the EU, US and ROW

An understanding of the full clinical trial process, particularly related to all aspects of reporting

Medical writing experience for all phases (I-IV) of clinical trials, is preferred

Knowledge of ICH/GCP and EU Clinical Trial Directive

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

 

BENEFITS:

Bonus / Pension / Private Medical and Life Assurance

 

TO APPLY:

For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.

To apply, please click APPLY ONLINE.

 

KEYWORDS:

Medical Writer / Clinical Medical Writer / Bucks / Berks / UK / West London / Reading / Slough / Maidenhead / Windsor / Uxbridge / Henley / Marlow / Harrow / London / Medical Writing Jobs / Medical Writer

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

 

 

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