Job summary
· Rapidly expanding Healthcare company
· Office based Warrington, Cheshire
· 12 month contract initially, employed via Chiltern or freelance
The RS (Resourcing Solutions) department of Chiltern International acts in a similar way to that of a staffing solutions provider. The department is currently seeking a Regulatory Writer to work for our client, a rapidly expanding healthcare company with a commitment to providing novel drugs into the Renal disease and GI Disease areas. This would be a 12 month contract initially with the possibility of becoming permanent or extending.
Function summary:
To conduct and manage all the regulatory writing needs across its pre- and post-registration activities (clinical and non-clinical) ensuring that documentation meets the required regulatory standards such as ICH CTD, and contains appropriate information required by global regulatory authorities.
· Prepares regulatory documents such as clinical study reports, Investigator Brochures, Annual Updates, CTD tabular summaries in line with regulatory requirements and internal document standards
· Preparation of more complex regulatory documents (e.g. CTD Overviews, ISS/ISE, clinical and non-clinical regulatory responses, product labelling and post marketing documentation) as required with direction from other members of the team.
· Tracks and manages progress of CTD documentation
· Contributes to other non-regulatory medical writing activities as required.
· Contributes to development work in relation to document standards, template development, SOPs and other aspects of document management.
Funtion Description:
Other Requirements:
* B.Sc. or higher degree in life sciences.
* Experience in medical writing with good knowledge of clinical trials process
* Highly developed and proven medical writing skills, fluent in English
* Demonstrated success in the preparation of regulatory documents particularly clinical study reports
* Working knowledge of appropriate ICH guidance e.g. E3 and E6 and ideally CTD
* It would be beneficial for the candidate to have Phase III and writing of CTD document experience
* Experience of working with/within CROs
* Able & willing to travel [UK and abroad] (valid driving license required)
* Must be eligible to work in the UK
Offer:
Salary: On Application
Position Type: Full Time - Contract
Work location:
based in Warrington - home working is not an option
To apply, please send your CV to julia.wright@chiltern.com
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