Regulatory Medical Writer (CSR/IB/Narratives/12months)

Andover  ‐ Onsite
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Keywords

Description

I have a Regulatory Medical Writer (CSR/IB/Narratives) contract requirement (6-12 month) based in Andover MA. My client requires an experienced Regulatory Medical Writer who can hit the ground running in regulatory documents such as CSR's, IB's and Narratives.

Key skills and experience required:

-Proven track record in writing Clinical Study Reports (CSR), investigatory brochures (IB's) and SAE narratives

-Strong knowledge of FDA regulatory requirements

-IND/NDA submissions experience

-Knowledge of good publication practice (GPP) and ICH guidelines

-Strong ectd knowledge

The successful regulatory writer will join an existing team, but will need minimal supervision and refers independently to pre-established guidelines to perform the functions of the job. Some remote work is available for the right person.

If you are interested please attach an up to date CV and I will be in touch.

To find out more about Real please visit www.realstaffing.com
Start date
04/2014
Duration
12 months
From
Real Staffing
Published at
11.04.2014
Project ID:
693629
Contract type
Freelance
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