Pharmaceutical Jobs - Clinical Research Jobs

Position

Regulatory/Medical Writer – Medical Communications – Horsham, West Sussex

Company

Additional Resources Ltd.

Location

Horsham

Country

United Kingdom

Job Description

Regulatory/Medical Writer – Medical Communications – Horsham, West Sussex – Salary £35–45k depending on experience

Company

This dynamic organisation is dedicated to providing high quality medical writing and regulatory affairs consulting and support services to global healthcare companies. Due to significant growth in demand for their services, they are seeking to expand an already highly accomplished writing team.
They have a permanent position for a Regulatory/Medical Writer to work cross a wide range of therapeutic areas and type of documentation.

Role

You will have experience in the preparation of documents such as:

• Clinical Study Reports - Phases I – IV
• Investigator brochures - de novo or annual updates
• Investigational Medicinal Product Dossiers (IMPD)
• All components of the CTD
• Clinical expert statements and case narratives
• Annual Safety Reports (ASRs) and Periodic Safety Update Reports (PSURs)
• Signal evaluation and issue workups
• Benefit-Risk ratio assessments
• Risk Management Plans

Candidate skills

The suitable candidate should have the following attributes:

• Graduate scientist in a life science (biology, chemistry, pharmacy, animal or human medicine), preferably at PhD level
• At least 5 years of experience in medical/regulatory writing gained within the pharmaceutical industry or CRO environment with a proven track record in successful submissions
• Understanding of the principles of drug development and applicable regulatory guidelines
• Customer-focussed approach – ability to solve problems, instil confidence and gain trust
• Excellent command of English and strong organisational, communication, literacy and numeracy skills; ability to manage and prioritise multiple tasks, often to tight deadlines
• Keen eye for detail; ability to assimilate large volumes of data and produce clear, accurate and compelling text in compliance with regulatory requirements
• High-level awareness of current practice in medical writing, medical information techniques, and technology relating to preparation of regulatory documentation; strong word processing skills.
• Ability to work in a team and to assume responsibility for project management;
You must be eligible to live and work in the UK to be considered for this position

If you would like the opportunity to be part of a successful, busy, dedicated and growing team, and to make a direct and positive contribution to further growth and development of their medical writing services, please send a CV and covering letter to richard@additionalresources.net.

Package

£35-45k depending on experience

Additional Resources Ltd is an Employment Business and an Employment Agency as defined within The Conduct of Employment Agencies & Employment Businesses Regulations 2003

Key words – Regulatory – Medical – Writing - Scientific- Medical Information Techniques – Regulatory Documentation – Life Sciences – PhD – Pharmaceutical Industry – Consulting – CRO – Clinical Study Reports – Drug Development – Risk Management Plans – Annual Safety Reports – Investigational Medicinal Product Dossiers

Company Profile

Additional Resources provide a highly specialist and comprehensive recruitment service for vacancies in many disciplines across the UK. - Accountancy - Banking & Finance - Engineering - Education & Training - IT & Telecoms - Legal - Pharmaceutical & Healthcare - Public Sector - Sales & Marketing We are committed to ensuring that we save you valuable time and add real value by partnering with you throughout your recruitment process. - Our Recruitment Consultants have considerable experience in their sectors and most have been with us for many years, giving stability and continuity to Client relationships.

Job Type

Full Time

Salary

From 35000 To 45000 £ Per Annum

Skills Required

Graduate scientist in a life science

Company's Job URL

http://www.additionalresources.net

Reference

012204

Posted On

14 July 2010

Last Date to Apply

14 September 2010

Important Notice

For jobs based in the EU it is unlawful to employ a person who does not have permission to live and work in the EU. Unless the job advert states otherwise, please ensure you have this permission before applying.

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