Regulatory & Medical Writer

Charlotte, NC

Job ID: 128935 Industry: CLINICAL

           

Regulatory & Medical Writer

Project Description:                                                     

Our client is a large biologics company who is currently looking for a Regulatory/Medical writer to help with a series of products.  The client currently has a product that they are trying to register in a foreign market.  The clinical data being presented is outdated and needs to be reformatted in accordance to current regulations.  They are looking for someone who has experience working with the Japan market with protein based products.

 

Day to Day Responsibilities:

This consultant will be responsible for updating the client’ s clinical summary reports for a registration in the Japanese market.   Right now, the client has clinical data that was created in the 1980’ s and 90’ s and is not up to the current standards for Japan.  They need someone to come in and look at the countries responses for their clinical summaries, determine what needs to be changed and update the documents accordingly.  The consultant will only have to update the information, not write a dossier from scratch.  Most of the updates will be in module 2. As this client works primarily with biologics, this consultant should have experience working with protein based products.

Required Skills:

RA Biologics

Clinical Summary updates

 

Job Type: Contract

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