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Senior Medical Writer ? London ? Reports to CEO

Job No:

43605957

Employer Reference:

SOC Code:

Wage

Competitive

Hours

Location

Bedfordshire UK

Duration

Full time

Date posted

May 19, 2017

Closing date

Pension details

Description

Responsibilities:· Act as Regulatory representative on different projects by providing your clinical expertise and knowledge.· Responsible for identifying the required documentation and any content to deliver successful reports according to the clients? programs.· Responsible for draft or review effectively regulatory and clinical documents (clinical study reports, investigator brochures, clinical study protocols/amendments, clinical summaries and clinical overview).· Understand the organisation?s system in order to instruct new professionals.· Support when needed to complete the writing of regulatory documents that contribute on the negotiation with Regulatory bodies such as PIP?s or Orphan Drug Designation applications.Requirements:· Minimum of 2 years of experience in the Medical Writing field is required· Experience reviewing and preparing clinical documents meeting the EMA and FDA regulatory guidance· Solid understanding of the CFR, FDA/ICH guidelines· Fluent English required (oral and written).· Excellent analytical and communication skills both verbal and written.This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to ?Chris? at cswain@barringtonjames.com cswain (at) barringtonjames (dot) com alongside a copy of your CV. Posted by Chris Swain Team Sales Manager https://uk.linkedin.com/in/christopherpswain

How to apply

https://jobsearch.direct.gov.uk/GetJob.aspx?JobID=43605957

Employer

Adzuna

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