A Junior Medical Writer is required to join a Regulatory Affairs Consultancy based in Cambridge. This is an excellent opportunity to work with a very busy and fast growing company with excellent prospects to progress.
- Prepare tabulated summaries along with preparation of in-text tables or narratives for the Senior Medical Writers or Medical Writer.
- Create of hyperlinks and bookmarks as required.
- Carry out numeric Quality Control of documents as required under the supervision of the Medical Writer.
- Plan schedule and track all assigned medical writing activities to ensure high quality, timely and accurate completion.
- Provide regular status updates to the Medical Writer for all assigned medical writing activities.
- Under supervision write low complexity CSR /NCSR.
- Compile current study reports within the EDMS environment
- Requesting required documents from the client, or other departments as appropriate
- Checking documents for compliance with EDMS requirements
- Entering documents into the EDMS structure
- Interact and effectively communicate with other groups in order to source clinical documents as required.
- Assessing documents for completeness and quality
- Produce documents using other software packages as required.
- Perform any other activity as may reasonably be required from time to time.
- Complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the company
Location: Cambourne, Cambridge
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