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Manager, Regulatory Medical Writing

Job Title: Manager, Regulatory Medical Writing
Contract Type: Fixed Term
Location: Scotland,
Industry:
Salary: Negotiable
Start Date: 11/07/16
Reference: 68535-PHARM-JKB
Contact Name: Jake Byrne
Contact Email: jake.byrne@volt.eu.com
Job Published: January 20, 2017 17:23

Job Description

Volt Europe are working on an EXCLUSIVE BASIS with a Global Pharmaceutical company to support the growth of their Global Medical Writing team.

Part of this includes a key hire for a Manager of Regulatory Medical Writing to be based in their offices.


Key requirements:

* Prepares, edits and reviews clinical documents
* Contributes to all document creation/review/approval SOPs
* Provide MW support to the publication planning and external presentations for study teams
* Experience authoring CTD Module 2 for NDAs and MAAs
* Understanding of clinical regulatory documentation requirements.
* Experience as lead-writer for key documents in major US and international regulatory submissions.
* Experience managing medical/scientific communication vendors and contract medical writers


Required:

- BS/MS degree in Life Sciences or Health Related Science degree
- Minimum of 8 years in regulatory medical writing for a pharmaceutical, biotechnology, or contract research company


Our client is willing to offer relocation support, an excellent benefits package, strong salary and a developmental opportunity.


If you would like to know more, get in touch with Jake Byrne from Volt Europe on +44 1737 236 793.



KEYWORDS:

Clinical Writing / Regulatory Writing / Medical Writing / CTD / Clinical Study Reports / Regulatory Documents / Regulatory / Scientific Writing / NDA / Senior Medical / Medical Affairs / Clinical Research / London / Manchester / Guildford / Bracknell / Oxford / Macclesfield / Liverpool / Glasgow / Edinburgh