Regulatory Writer

Date Posted: Thursday, 16th of February 2012

Salary: £45,000 - £51,000

Start Date: ASAP

Telephone: 01438 870024

Location: West Sussex

Discipline:Regulatory Affairs

Consultant Name: Meera Pattni

Sector: Pharmaceutical

Description

Regulatory Writer

Main responsibilities:
You should be able to demonstrate experience in the preparation of documents such as:
Clinical Study Protocols and Report - Phases I-IV and non interventional studies.
All components^of the common technical document, especially Module 2 and 5.
Paediatric Investigator Plans.
Investigator brochures.
Clinical Trial Applications.
Patient information leaflets and informed consent forms.
PSURs, Risk Management Plans, signalevaluations, case narratives.
Clinical Evaluations and Technical Files for medical devices.
Health Technology Assessment.
Digital Messaging.

Candidate specification:
Life sciences degree is essential. MSc or PhD preferred.
Substantial experience in a regulatory / medical writing role gained with a pharmaceutical company or CRO with a proven track record across a range of therapeutics area.
Understanding of the principals of drug development and appreciation of current regulatory environment.
Customer focussed approach.
Excellent command of English and strong organisational and communication skills.
Keen eye for detail.
Ability to work as part of a team or independently.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL23727 in all correspondence.

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