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Job Details

Senior Medical Writer

Company: Hydrogen Group
Location: Germany
Reference: JO-1611-899298
Closing Date: 26 Jan 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Senior Medical Writer Permanent Berlin, Germany We are looking for an experienced Medical Writer to work for a consultancy based in Berlin, Germany. This is a permanent role working with both clinical and regulatory submission documents. Your responsibilities will include: * Writing clinical documents incl. ...

Requirements:

Senior Medical Writer
Permanent
Berlin, Germany

We are looking for an experienced Medical Writer to work for a consultancy based in Berlin, Germany. This is a permanent role working with both clinical and regulatory submission documents.

Your responsibilities will include:


* Writing clinical documents incl. Clinical Protocols, Clinical Study Reports, ICFs, Investigator Brochures and medical communication materials
* Writing of Pharmacovigilence documents for regulatory submission in the clinical development, market authorisation and post-marketing phases such as RMPs, PBRERs and DSURs
* Consulting and advice on contents of clinical and PV documents
* Management of projects and project teams including the coaching of junior writers
* Communication with clients and regulatory authorities.

Requirements:


* Very good understanding of clinical and PV data analysis
* Very good understanding of drug development and PV processes and key regulatory requirements (incl. ICH topics E2C, E2F, E3, E6 and EMA GVP legislation)
* Very good knowledge of medical terminology
* High proficiency in MS Office and reference management software
* Excellent verbal and written skills in German and English
* 3 years of experience as a medical writer with experience in PV documents

If you are interested in hearing more about this opportunity please email jessicaadams@hydrogengroup.com with your CV and an appropriate time to organise a phone call or call +44 20 7002 0139.

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Apply for this job: Senior Medical Writer

Contact Information:

Address:  Head Office
30 Eastcheap London
EC3M 1HD
England
Tel:  +44 (0) 207 002 0000

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