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Senior Medical Writer ? London ? Reports to CEO

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Bedfordshire UK


Full time

Date posted

May 19, 2017

Closing date

Pension details


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 (at) barringtonjames (dot) com alongside a copy of your CV. Posted by Chris Swain Team Sales Manager

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