Pre-Clinical Writer

Location
Cambridge
Salary
£0 per annum
Posted
07 Sep 2017
Closes
05 Oct 2017
Ref
J4119
Contact
William Blohm
Contract Type
Permanent
Hours
Full Time
The Role

Key Responsibilities

This role will primarily entail ensuring preclinical data are available, identified and appropriately assembled for regulatory submissions throughout the product life cycles, including arranging and authorising of preclinical regulatory documents. These responsibilities include, but are not limited to:

- Prepare relevant preclinical sections of documents for Regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), New Drug Applications (NDA), Market Authorisation Applications (MAA), Orphan Drug Applications and Investigator Brochures (IB)
- Maintains an up-to-date knowledge of regulatory guidance to ensure appropriate preclinical data are available for regulatory submissions
- Prepares and manages the preparation of preclinical sections of briefing documents for meetings with competent authorities
- Coordinates with Regulatory Affairs Department
- Contributes to the preparation of SOPs for the Preclinical Department
- Organises quality control of required documents and / or sections as appropriate

Essential Skills

- A graduate degree in a Science/Life Science discipline or another appropriate scientific discipline
- Good previous experience writing and reviewing preclinical study-related documents within the pharmaceutical, biotechnology and/or contract research organisations
- Strong scientific background
- Ability to plan and communicate clearly
- Working knowledge of Word, Excel, PowerPoint, Endnote and search engines
- Excellent communication skills (written and verbal)

Desirable Skills

- Ability to QC documents
- Knowledge of appropriate regulatory guidelines and legislation
- Ability to assimilate and critique scientific writing

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