CMC Technical Writer - ATMP

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Discipline
Regulatory Affairs
,
CMC
Hours
Part Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
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Job Details
Company

Job Details

I am currently partnered with a Regulatory Affairs Consultancy who is seeking a CMC Technical Writer to support them in CMC Writing for ATMPs. My Client has over 500 Clients offering Regulatory Affairs services globally, this particular project requires an experienced freelancer to assist them remotely on a part time basis.

The CMC Technical Writer will be responsible for:

• Writing the core quality sections for MAAs, BLAs/NDAs, IMPDs and INDs and briefing material to support agency meetings in the US and EU
• Supporting the Regulatory Teams with ATMP and CMC expertise

Suitable candidates will have:

• 5 years’ experience in CMC Technical Writing
• Experience in ATMPs
• Preferable experience with regulatory filings (IND/IMPD, BLA/NDA/MAA)
• EU and US Market experience

I specialise in recruiting Regulatory Affairs professionals throughout Europe, if you would like to speak to me regarding one of my current vacancies, or simply be made aware of opportunities as they arise then please call me today on +44 (0)1293 77 66 44 for a confidential discussion.

Alternatively e-mail me on
JASmith@barringtonjames.com
.
I look forward to hearing from you soon!

Jasmine Smith

Contract Consultant ~ Regulatory Affairs

+ 44 (0)1293 77 66 44

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info

Website
https://barringtonjames.com/
Telephone
01293 776644
Location
The Galleria
Station Road
Crawley
West Sussex
RH10 1WW
United Kingdom
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